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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04424316
Registration number
NCT04424316
Ethics application status
Date submitted
3/06/2020
Date registered
9/06/2020
Date last updated
25/03/2025
Titles & IDs
Public title
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
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Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
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Secondary ID [1]
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2019-002943-85
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Secondary ID [2]
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C3671008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection
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0
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Infection
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0
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0
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Other infectious diseases
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Infection
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0
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - RSVpreF
Treatment: Other - Placebo
Experimental: RSVpreF vaccine - RSVpreF
Placebo comparator: Placebo dose - Placebo
Treatment: Other: RSVpreF
RSV vaccine (RSVpreF)
Treatment: Other: Placebo
Placebo
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
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Assessment method [1]
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Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: infant with an MA-RTI visit with age related fast breathing (respiratory rate \[RR\] more than or equal to \[\>=\] 60 breaths per minute \[bpm\] for less than \[\<\] 2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or oxygen saturation (SpO2) \<95 percent (%) or chest wall indrawing and RSV positive test results by reverse transcription-polymerase chain reaction (RT-PCR) testing of midturbinate nasal swab samples.
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Timepoint [1]
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Within 90 days after birth
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Primary outcome [2]
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Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
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Assessment method [2]
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Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
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Timepoint [2]
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Within 120 days after birth
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Primary outcome [3]
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Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
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Assessment method [3]
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Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
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Timepoint [3]
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Within 150 days after birth
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Primary outcome [4]
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Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
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Assessment method [4]
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Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
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Timepoint [4]
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Within 180 days after birth
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Primary outcome [5]
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Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
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Assessment method [5]
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Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or intensive care unit (ICU) admission for more than (\>) 4 hours or failure to respond/unconscious.
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Timepoint [5]
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0
Within 90 days after birth
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Primary outcome [6]
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Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
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Assessment method [6]
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Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.
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Timepoint [6]
0
0
Within 120 days after birth
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Primary outcome [7]
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Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
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Assessment method [7]
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Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.
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Timepoint [7]
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0
Within 150 days after birth
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Primary outcome [8]
0
0
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
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Assessment method [8]
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Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.
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Timepoint [8]
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Within 180 days after birth
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Primary outcome [9]
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Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)
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Assessment method [9]
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AESI are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants and their infants prior to/during delivery and at birth. For infant participants the following were considered as protocol defined AESIs: Preterm birth (born at \<37 weeks gestation); birth weight 1001-2500 grams; developmental delay; positive viral (polymerase chain reaction \[PCR\] or antigen-based) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), when not reported during MA-RTI visit, were reported as SARS-CoV-2 test positive. Extremely preterm birth (\<28 weeks) and extremely low birth weight (=\<1000 grams \[g\]) were reported as serious AESIs.
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Timepoint [9]
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From birth to 24 months of age
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Primary outcome [10]
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Percentage of Infant Participants With Neonatal Deaths (Safety)
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Assessment method [10]
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Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.
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Timepoint [10]
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Within 1 Month after birth
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Primary outcome [11]
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Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)
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Assessment method [11]
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Congenital malformations/ anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.
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Timepoint [11]
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At birth
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Primary outcome [12]
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Percentage of Infant Participants With Other Neonatal Events (Safety)
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Assessment method [12]
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Other Neonatal problem included dysmaturity, neonatal illness, hospitalization, drug therapies, and neonatal death.
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Timepoint [12]
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Within 1 Month after birth
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Primary outcome [13]
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Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)
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Assessment method [13]
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APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.
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Timepoint [13]
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1 minute after birth
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Primary outcome [14]
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Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)
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Assessment method [14]
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APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.
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Timepoint [14]
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0
5 minutes after birth
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Primary outcome [15]
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Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)
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Assessment method [15]
0
0
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.
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Timepoint [15]
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10 minutes after birth
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Primary outcome [16]
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Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)
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Assessment method [16]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [16]
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From birth to 1 month of age
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Primary outcome [17]
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Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)
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Assessment method [17]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
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Timepoint [17]
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From birth to 6 months of age
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Primary outcome [18]
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Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)
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Assessment method [18]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
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Timepoint [18]
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From birth to 12 months of age
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Primary outcome [19]
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Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)
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Assessment method [19]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
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Timepoint [19]
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From birth to 24 months of age
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Primary outcome [20]
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Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety)
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Assessment method [20]
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Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit= 0.5 centimetre (cm). Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for the severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified person.
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Timepoint [20]
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From Day 1 to Day 7 after vaccination
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Primary outcome [21]
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Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety)
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Assessment method [21]
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Systemic events included: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in an e-diary. Fever was defined as an oral temperature \>=38.0 degree Celsius \[C\]) and classified as mild (38.0 to 38.4), moderate (38.5 to 38.9), severe (39.0 to 40.0) and grade 4 (\>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours \[H\]), moderate (\>2 times in 24 H), severe (required intravenous \[IV\] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (\>=6 in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified person.
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Timepoint [21]
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From Day 1 to Day 7 after vaccination
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Primary outcome [22]
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Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)
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Assessment method [22]
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure.
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Timepoint [22]
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0
From vaccination on Day 1 up to 1 month after vaccination
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Primary outcome [23]
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0
Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)
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Assessment method [23]
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0
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
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Timepoint [23]
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0
From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)
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Secondary outcome [1]
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Percentage of Infant Participants With Cases of Hospitalization Due to RSV Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)
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Assessment method [1]
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0
Results are reported as confirmed by endpoint adjudication committee.
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Timepoint [1]
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0
Within 90, 120, 150, 180 and 360 days after birth
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Secondary outcome [2]
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0
Percentage of Infant Participants With MA-LRTI Cases Due to Any Cause With Protocol Defined Criteria Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)
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Assessment method [2]
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MA-LRTI cases due to any cause was defined as an infant with a MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing.
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Timepoint [2]
0
0
Within 90, 120, 150, 180 and 360 days after birth
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Secondary outcome [3]
0
0
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)
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Assessment method [3]
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0
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.
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Timepoint [3]
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Within 210, 240, 270 and 360 days after birth
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Eligibility
Key inclusion criteria
Inclusion Criteria - Maternal Participants:
* Healthy women =49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Receiving prenatal standard of care based on country requirements.
* Had a fetal anomaly ultrasound examination performed at =18 weeks of pregnancy with no significant fetal abnormalities observed.
* Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
* Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
* Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
* Expected to be available for the duration of the study and can be contacted by telephone during study participation.
* Participant is willing to give informed consent for her infant to participate in the study.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.
Inclusion Criteria -Infant Participants:
* Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
* Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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Minimum age
0
Years
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Maximum age
49
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria - Maternal Participants:
* Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
* Current pregnancy resulting from in vitro fertilization.
* Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:
* Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
* Placental abnormality.
* Polyhydramnios or oligohydramnios.
* Significant bleeding or blood clotting disorder.
* Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
* Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
* Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:
* Prior preterm delivery =34 weeks' gestation.
* Prior stillbirth or neonatal death.
* Previous infant with a known genetic disorder or significant congenital anomaly.
* Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations).
* Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment.
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation.
* Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for =14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids.
* Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
* Receipt of blood or plasma products or immunoglobulin (Ig), from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
* Previous vaccination with any licensed or investigational RSV vaccine or planned. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participants who are breastfeeding at the time of enrollment.
Exclusion Criteria -Infant Participants:
o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/10/2023
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Sample size
Target
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Accrual to date
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Final
14727
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Women's and Children's Hospital - North Adelaide
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Recruitment hospital [2]
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Monash Children's Hospital - Clayton
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Recruitment hospital [3]
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Barwon Health, University Hospital Geelong - Geelong
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Recruitment hospital [4]
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Telethon Kids Institute - Nedlands
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Recruitment hospital [5]
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St John of God Hospital Subiaco - Subiaco
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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State/province [3]
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Arkansas
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United States of America
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State/province [4]
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California
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United States of America
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State/province [5]
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Colorado
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United States of America
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State/province [6]
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Connecticut
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United States of America
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State/province [7]
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District of Columbia
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United States of America
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State/province [8]
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Florida
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United States of America
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State/province [9]
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Georgia
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United States of America
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State/province [10]
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Idaho
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United States of America
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State/province [11]
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Indiana
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United States of America
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State/province [12]
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Iowa
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United States of America
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State/province [13]
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Kansas
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United States of America
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State/province [14]
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Kentucky
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United States of America
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State/province [15]
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Louisiana
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United States of America
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State/province [16]
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Massachusetts
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United States of America
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State/province [17]
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Michigan
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United States of America
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State/province [18]
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Mississippi
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United States of America
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State/province [19]
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Missouri
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United States of America
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State/province [20]
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Montana
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United States of America
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State/province [21]
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Nebraska
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United States of America
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State/province [22]
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New Jersey
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Country [23]
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United States of America
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State/province [23]
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New Mexico
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Country [24]
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United States of America
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State/province [24]
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New York
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Country [25]
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United States of America
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State/province [25]
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North Carolina
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Country [26]
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United States of America
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State/province [26]
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Ohio
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Country [27]
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United States of America
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State/province [27]
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Oklahoma
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Country [28]
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United States of America
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State/province [28]
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Pennsylvania
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Country [29]
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United States of America
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State/province [29]
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South Carolina
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Country [30]
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United States of America
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State/province [30]
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South Dakota
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Country [31]
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United States of America
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State/province [31]
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Tennessee
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Country [32]
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United States of America
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State/province [32]
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Texas
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Country [33]
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United States of America
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State/province [33]
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Utah
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Country [34]
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United States of America
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State/province [34]
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Virginia
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Country [35]
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United States of America
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State/province [35]
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Washington
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Country [36]
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United States of America
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State/province [36]
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West Virginia
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Country [37]
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United States of America
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State/province [37]
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Wisconsin
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Country [38]
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Argentina
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State/province [38]
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Buenos Aires
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Country [39]
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Argentina
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State/province [39]
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Santa FE
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Country [40]
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Argentina
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State/province [40]
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Tucuman
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Country [41]
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Argentina
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State/province [41]
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Caba
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Country [42]
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Argentina
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State/province [42]
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Salta
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Country [43]
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Brazil
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State/province [43]
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RS
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Country [44]
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Brazil
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State/province [44]
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SC
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Country [45]
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Brazil
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State/province [45]
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SP
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Country [46]
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Canada
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State/province [46]
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Nova Scotia
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Country [47]
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Canada
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State/province [47]
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Quebec
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Country [48]
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Chile
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State/province [48]
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Región DE LOS Lagos
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Country [49]
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Chile
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State/province [49]
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Región Metropolitana
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Country [50]
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Denmark
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State/province [50]
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Aarhus N
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Country [51]
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Denmark
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State/province [51]
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Hillerod
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Country [52]
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Denmark
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State/province [52]
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Hvidovre
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Country [53]
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Denmark
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State/province [53]
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Odense
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Country [54]
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Finland
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State/province [54]
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Helsinki
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Country [55]
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Finland
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State/province [55]
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Kokkola
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Country [56]
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Finland
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State/province [56]
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Oulu
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Country [57]
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Finland
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State/province [57]
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Pori
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Country [58]
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Finland
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State/province [58]
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Seinajoki
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Country [59]
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Finland
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State/province [59]
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Tampere
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Country [60]
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Finland
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State/province [60]
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Turku
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Country [61]
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Gambia
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State/province [61]
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Fajara KMC
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Country [62]
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Gambia
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State/province [62]
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Sukuta
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Country [63]
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Japan
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State/province [63]
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Fukui
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Country [64]
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Japan
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State/province [64]
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Hyogo
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Country [65]
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Japan
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State/province [65]
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Kanagawa
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Country [66]
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Japan
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State/province [66]
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Kyoto
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Country [67]
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Japan
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State/province [67]
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MIE
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Country [68]
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Japan
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State/province [68]
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Miyagi
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Country [69]
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Japan
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State/province [69]
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Oita
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Country [70]
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Japan
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State/province [70]
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Okinawa
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Country [71]
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Japan
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State/province [71]
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Osaka
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Country [72]
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Japan
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State/province [72]
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Tokyo
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Country [73]
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Japan
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State/province [73]
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Saitama
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Country [74]
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Japan
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State/province [74]
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Shizuoka
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Country [75]
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Korea, Republic of
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State/province [75]
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Gwangju
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Country [76]
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Korea, Republic of
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State/province [76]
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Seoul
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Country [77]
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Mexico
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State/province [77]
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Ciudad DE Mexico
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Country [78]
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Mexico
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State/province [78]
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Hidalgo
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Country [79]
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Mexico
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State/province [79]
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Nuevo LEON
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Country [80]
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Mexico
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State/province [80]
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Durango
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Country [81]
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Mexico
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State/province [81]
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Veracruz
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Country [82]
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Netherlands
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State/province [82]
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Hoofddorp
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Country [83]
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Netherlands
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State/province [83]
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Utrecht
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Country [84]
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New Zealand
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State/province [84]
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Auckland
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Country [85]
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New Zealand
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State/province [85]
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Canterbury
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Country [86]
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New Zealand
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State/province [86]
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Christchurch
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Country [87]
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New Zealand
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State/province [87]
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Wellington
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Country [88]
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Philippines
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State/province [88]
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Metro Manila
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Country [89]
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South Africa
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State/province [89]
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FREE State
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Country [90]
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South Africa
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State/province [90]
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Gauteng
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Country [91]
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South Africa
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State/province [91]
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Limpopo
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Country [92]
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South Africa
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State/province [92]
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Western CAPE
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Country [93]
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South Africa
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State/province [93]
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Cape Town
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Country [94]
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South Africa
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State/province [94]
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Worcester
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Country [95]
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Spain
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State/province [95]
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A Coruna
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Country [96]
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Spain
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State/province [96]
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Malaga
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Country [97]
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Spain
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State/province [97]
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Madrid
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Country [98]
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Spain
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State/province [98]
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Mostoles
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Country [99]
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Spain
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State/province [99]
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Valencia
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Country [100]
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Taiwan
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State/province [100]
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Hsinchu
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Country [101]
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Taiwan
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State/province [101]
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Kaohsiung
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Taiwan
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State/province [102]
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Taipei City
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Country [103]
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Taiwan
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State/province [103]
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Taipei
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Country [104]
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Taiwan
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State/province [104]
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Taoyuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
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Trial website
https://clinicaltrials.gov/study/NCT04424316
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Trial related presentations / publications
Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/16/NCT04424316/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT04424316/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04424316
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