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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05415462
Registration number
NCT05415462
Ethics application status
Date submitted
8/06/2022
Date registered
13/06/2022
Date last updated
24/09/2024
Titles & IDs
Public title
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
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Scientific title
A Phase 3, Randomized, Stratified, Observer-blind, Active-Controlled Study to Evaluate the Immunogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older
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Secondary ID [1]
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mRNA-1010-P301
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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:
Seasonal Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - mRNA-1010
Treatment: Other - Fluarix Tetra
Experimental: mRNA-1010 - Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Active comparator: Fluarix Tetra - Participants will receive a single dose of Fluarix Tetra by IM injection on Day 1.
Treatment: Other: mRNA-1010
Sterile liquid for injection
Treatment: Other: Fluarix Tetra
Sterile suspension for injection
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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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Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay for Vaccine-matched Influenza A and B Strains
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Assessment method [1]
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Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
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Timepoint [1]
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Day 29
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Primary outcome [2]
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Percentage of Participants Reaching Seroconversion at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
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Assessment method [2]
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Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as either a Baseline HAI titer \<1:10 and a post-Baseline titer =1:40 or a Baseline HAI titer =1:10 and a minimum 4-fold rise in post-Baseline HAI Ab titer.
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Timepoint [2]
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Day 29
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Primary outcome [3]
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Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
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Assessment method [3]
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Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
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Timepoint [3]
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7 days post-vaccination
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Primary outcome [4]
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Number of Participants With Unsolicited AEs
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Assessment method [4]
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An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
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Timepoint [4]
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Up to 28 days post-vaccination
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Primary outcome [5]
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Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation
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Assessment method [5]
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An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 \[COVID-19\] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (Day 361) are reported in this outcome measure.
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Timepoint [5]
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Day 1 through Day 361 (Month 12)
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Secondary outcome [1]
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Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus
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Assessment method [1]
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A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (=1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2 degrees Celsius (°C) (\>99 degrees Fahrenheit \[°F\]), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.
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Timepoint [1]
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14 days post-vaccination through Day 181 (Month 6)
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Secondary outcome [2]
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Number of Participants With First Episode of RT-PCR Confirmed Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Strain of Influenza Virus
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Assessment method [2]
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A CDC-defined ILI was defined as body temperature =37.8°C (100°F) accompanied by cough and/or sore throat.
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Timepoint [2]
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14 days post-vaccination through Day 181 (Month 6)
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Secondary outcome [3]
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Number of Participants With First Episode of RT-PCR-Confirmed Protocol-Defined ILI Caused by Any Strain of Influenza Virus in Participants Aged 50 Years and Older or 65 Years and Older
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Assessment method [3]
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A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (=1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2°C (\>99°F), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea.
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Timepoint [3]
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14 days post-vaccination through Day 181 (Month 6)
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Secondary outcome [4]
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Percentage of Participants With HAI Titer = 1:40 at Day 29
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Assessment method [4]
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Seasonal influenza A strains included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage.
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Timepoint [4]
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Day 29
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Secondary outcome [5]
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Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay for Vaccine-matched Influenza A and B Strains
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Assessment method [5]
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The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Seasonal influenza A included H1N1 and H3N2 and seasonal influenza B strains included Victoria-lineage and Yamagata-lineage. Fold-rise was calculated by dividing post-vaccination results by the baseline value. 95% confidence interval (CI) for GMFR was calculated based on the t distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
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Timepoint [5]
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Baseline, Day 29
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Eligibility
Key inclusion criteria
* Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the United States (US) CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
* Participant is acutely ill or febrile (temperature =38.0? [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
* Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
* Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to the Screening Visit (for corticosteroids, =10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
* Participant has received any vaccine authorized or approved by local health agency =28 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study injection.
* Participant is not aware whether they have received an influenza vaccine in the past 12 months or has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1.
* Participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Screening Visit.
* Participant has donated =450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
Note: Other inclusion and exclusion criteria may apply.
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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
6/06/2022
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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
4/09/2023
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Sample size
Target
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Accrual to date
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Final
6102
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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PARC Clinical Research - Adelaide
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Paratus Clinical Research - Brisbane Clinic - Albion
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Paratus Clinical Research - Western Sydney - Blacktown
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [5]
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Paratus Clinical Research - Canberra - Bruce
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Recruitment hospital [6]
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Emeritus Research - Camberwell
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Recruitment hospital [7]
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Monash Health, Monash Medical Centre - Clayton
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Recruitment hospital [8]
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Paratus Clinical Research - Central Coast - Kanwal
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Recruitment hospital [9]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [10]
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University of Melbourne - Parkville
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Recruitment hospital [11]
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University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [12]
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Griffith University - Southport
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Recruitment hospital [13]
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AusTrials (Wellers Hill) - Tarragindi
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Recruitment hospital [14]
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CMAX - Woodville - Woodville
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Albion
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Recruitment postcode(s) [3]
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- Blacktown
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Recruitment postcode(s) [4]
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- Brookvale
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Recruitment postcode(s) [5]
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- Bruce
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Recruitment postcode(s) [6]
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- Camberwell
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Recruitment postcode(s) [7]
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- Clayton
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Recruitment postcode(s) [8]
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- Kanwal
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Recruitment postcode(s) [9]
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- Maroubra
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Recruitment postcode(s) [10]
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- Parkville
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Recruitment postcode(s) [11]
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- Sippy Downs
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Recruitment postcode(s) [12]
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- Southport
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Recruitment postcode(s) [13]
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- Tarragindi
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Recruitment postcode(s) [14]
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- Woodville
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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State/province [2]
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autónoma Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Ciudad De Cordoba
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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Río Cuarto
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Argentina
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San Miguel de Tucumán
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Colombia
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Acacías
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Colombia
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Aguazul
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Colombia
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Armenia
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Chía
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Colombia
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Floridablanca
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Colombia
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Girardot
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Colombia
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Ibague
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Colombia
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Medellín
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Colombia
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Santiago de Cali
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Colombia
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Soledad
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Colombia
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Yopal
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Panama
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Ciudad De Panamá
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Panama
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State/province [24]
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Panamá
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Country [25]
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Philippines
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State/province [25]
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Iloilo City
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Philippines
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State/province [26]
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Mandaluyong City
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Country [27]
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Philippines
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State/province [27]
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Manila City
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Country [28]
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Philippines
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State/province [28]
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Muntinlupa
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Country [29]
0
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Philippines
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State/province [29]
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Pasay
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Country [30]
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Philippines
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State/province [30]
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Quezon City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ModernaTX, Inc.
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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
The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29, and to evaluate the safety and reactogenicity of mRNA-1010.
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Trial website
https://clinicaltrials.gov/study/NCT05415462
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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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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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/62/NCT05415462/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/62/NCT05415462/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/NCT05415462
Download to PDF