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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04605159




Registration number
NCT04605159
Ethics application status
Date submitted
22/10/2020
Date registered
27/10/2020

Titles & IDs
Public title
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age
Secondary ID [1] 0 0
2020-001355-40
Secondary ID [2] 0 0
212171
Universal Trial Number (UTN)
Trial acronym
GRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RSV MAT
Treatment: Drugs - Placebo

Experimental: RSV MAT Group - Mother - Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.

Placebo comparator: Placebo Group - Mother - Maternal participants received a single dose of placebo administered at Day 1 in this study.

No intervention: RSV MAT Group - Infant - This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.

No intervention: Placebo Group - Infant - This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.


Treatment: Other: RSV MAT
One dose of RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm at Day 1.

Treatment: Drugs: Placebo
One dose of placebo (lyophilized sucrose reconstituted with NaCl solution) administered intramuscularly in the non-dominant arm at Day 1.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth
Timepoint [1] 0 0
From birth to Day 181 post-birth
Primary outcome [2] 0 0
Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth
Timepoint [2] 0 0
From birth to Day 181 post-birth
Primary outcome [3] 0 0
Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
Timepoint [3] 0 0
From birth to Day 181 post-birth
Primary outcome [4] 0 0
Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth
Timepoint [4] 0 0
From birth to Day 181 post-birth
Primary outcome [5] 0 0
Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth
Timepoint [5] 0 0
From birth to Day 366 post-birth
Primary outcome [6] 0 0
Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth
Timepoint [6] 0 0
From birth to Day 366 post-birth
Primary outcome [7] 0 0
Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth
Timepoint [7] 0 0
From birth to Day 366 post-birth
Secondary outcome [1] 0 0
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth
Timepoint [1] 0 0
From birth to Day 181 post-birth
Secondary outcome [2] 0 0
Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth
Timepoint [2] 0 0
From birth to Day 181 post-birth
Secondary outcome [3] 0 0
Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth
Timepoint [3] 0 0
From birth to Day 181 post-birth
Secondary outcome [4] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
Timepoint [4] 0 0
From birth to Day 366 post-birth
Secondary outcome [5] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth
Timepoint [5] 0 0
From birth to Day 366 post-birth
Secondary outcome [6] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth
Timepoint [6] 0 0
From birth to Day 181 post-birth
Secondary outcome [7] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth
Timepoint [7] 0 0
From birth to Day 181 post-birth
Secondary outcome [8] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth
Timepoint [8] 0 0
From birth to Day 121 post-birth
Secondary outcome [9] 0 0
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth
Timepoint [9] 0 0
From birth to Day 121 post-birth
Secondary outcome [10] 0 0
Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth
Timepoint [10] 0 0
From birth to Day 181 post-birth
Secondary outcome [11] 0 0
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth
Timepoint [11] 0 0
From birth to Day 366 post-birth
Secondary outcome [12] 0 0
Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery
Timepoint [12] 0 0
From study intervention administration (Day 1) to Day 181 post-delivery
Secondary outcome [13] 0 0
RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery
Timepoint [13] 0 0
At Day 1 (before study intervention administration), at Day 31 and at delivery
Secondary outcome [14] 0 0
RSV-A Neutralizing Antibody Titers for Infant Participants at Delivery or Within 72 Hours After Birth
Timepoint [14] 0 0
At delivery or within 72 hours after birth
Secondary outcome [15] 0 0
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 43 Post-birth
Timepoint [15] 0 0
At Day 43 post-birth
Secondary outcome [16] 0 0
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 121 Post-birth
Timepoint [16] 0 0
At Day 121 post-birth
Secondary outcome [17] 0 0
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 181 Post-birth
Timepoint [17] 0 0
At Day 181 post-birth
Secondary outcome [18] 0 0
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery
Timepoint [18] 0 0
At delivery
Secondary outcome [19] 0 0
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth
Timepoint [19] 0 0
At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)
Secondary outcome [20] 0 0
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations
Timepoint [20] 0 0
At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)
Secondary outcome [21] 0 0
Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included
Timepoint [21] 0 0
From Day 1 to Day 7 included
Secondary outcome [22] 0 0
Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included
Timepoint [22] 0 0
From Day 1 to Day 7 included
Secondary outcome [23] 0 0
Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included
Timepoint [23] 0 0
From Day 1 to Day 30 included
Secondary outcome [24] 0 0
Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery
Timepoint [24] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [25] 0 0
Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery
Timepoint [25] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [26] 0 0
Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery
Timepoint [26] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [27] 0 0
Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery
Timepoint [27] 0 0
From Day 1 to Day 42 post-delivery, an average of 2 months
Secondary outcome [28] 0 0
Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery
Timepoint [28] 0 0
From Day 1 to Day 42 post-delivery, an average of 2 months
Secondary outcome [29] 0 0
Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery
Timepoint [29] 0 0
From Day 1 to Day 42 post-delivery, an average of 2 months
Secondary outcome [30] 0 0
Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth
Timepoint [30] 0 0
From birth to Day 42 post-birth, an average of 2 months

Eligibility
Key inclusion criteria
Maternal participants

* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.
* Age 18 to 49 years, inclusive, at the time of study intervention.
* Pre-pregnancy BMI 17.0 to 39.9 kg/m2, inclusive.
* In good general maternal health as established by medical history and clinical examination before entering into the study.
* Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome).
* At 24^0/7 to 34^0/7 weeks of gestation at the time of study vaccination (Visit 1), as established by:
* last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
* 1st or 2nd trimester U/S only, if LMP is unknown/uncertain
* Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
* No fetal genetic abnormalities (based on genetic testing, if performed).
* No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.
* Willing to provide cord blood.
* Who do not plan to give their child for adoption.
* Who plan to reside in the study area for at least one year after delivery.
* Willing to have the infant followed-up after delivery for a period of 12 months.

Infant participants

* Live-born from the study pregnancy.
* If required per local regulations/guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal participants Medical conditions

* History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
* Hypersensitivity to latex
* Significant complications in the current pregnancy:
* Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (<140mmHg and <90mmHg) through diet and/or antihypertensive medications
* Gestational diabetes not controlled by medication, diet and/or exercise
* Pre-eclampsia
* Eclampsia
* Intrauterine Growth Restriction/Fetal Growth Restriction
* Placenta previa
* Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation
* Polyhydramnios
* Oligohydramnios
* Preterm labour or history of preterm labour in the current pregnancy
* Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
* Cholestasis
* Other pregnancy-related complications (per investigator's judgement)
* Significant structural abnormalities of the uterus or cervix
* History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at =34 weeks gestation/3 or more consecutive spontaneous abortions
* Known HIV infection (as per serological tests performed during the current pregnancy)
* Known or suspected HBV or HCV infection
* Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex
* Active infection with tuberculosis
* Known or suspected impairment of the immune system
* Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
* Lymphoproliferative disorder or malignancy within 5 years before study vaccination
* Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
* Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care
* Any condition which would increase the risks of study participation to the unborn infant

Prior/Concomitant therapy

* Prior receipt of an RSV vaccine in the current pregnancy
* Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :
* For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
* For immunoglobulins: 3 months before the dose of study vaccine/product.

The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery

* Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
* Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens, Hepatitis B vaccines, and COVID-19 vaccines all of which may be administered according to standard of care =15 days before or after study vaccination
* Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery
* Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
* Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
* Prednisone =5 mg/day or equivalent for =14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
* Corticosteroids administered for fetal lung maturation

Prior/Concurrent clinical study experience

- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product

Other exclusions

* Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
* A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
* Consanguinity of maternal participant and her partner (second degree cousins or closer)
* Any study personnel or their immediate dependants, family or household members

Infant participants

* Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
* Any condition which would increase the risks of study participation to the infant
* Child in care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2023
Sample size
Target
Accrual to date
Final
11194
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Southport
Recruitment hospital [3] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [4] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [5] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Florida
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United States of America
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Idaho
Country [6] 0 0
United States of America
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Louisiana
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United States of America
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Michigan
Country [8] 0 0
United States of America
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Montana
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United States of America
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Nebraska
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United States of America
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New Mexico
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad AutOnoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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San Miguel de TucumAn
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Argentina
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Tucuman
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Bangladesh
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Matlab
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Bangladesh
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Sylhet
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Sint-Niklaas
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Caxias do Sul
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Nova IguaCu
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Brazil
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Porto Alegre
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Brazil
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RibeirAo PretoSP
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Brazil
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Santa Maria
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SAo JosE do Rio Preto
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Cali Colombia
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Colombia
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Chia
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Colombia
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Medellin
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Dominican Republic
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Santo Domingo Este
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Finland
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Helsinki
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Finland
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Kokkola
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Finland
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Oulu
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Finland
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Tampere
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Turku
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France
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Bordeaux
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Paris
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Pierre BEnite
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Comayagua
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Honduras
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India
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Kolkata
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India
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Mangalore
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India
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Mysore
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India
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Nagpur
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Pune
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India
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Vadu Budruk Pune
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Italy
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Bari
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Italy
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Messina
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Italy
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Milano
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Italy
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Novara
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Italy
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Palermo
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Italy
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Prato
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Italy
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Verona
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Chihuahua
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Mexico
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Monterrey
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Morelia
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Oaxaca
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Mexico
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San Juan Del RIo
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Mexico
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San Luis PotosI
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New Zealand
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Grafton Auckland
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New Zealand
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Papatoetoe Auckland
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New Zealand
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Wellington
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Panama
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Ciudad de Panama
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Panama
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Panama City
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Panama
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Panama
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Philippines
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Cavite
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Philippines
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Manila
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Soshanguve
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South Africa
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Soweto
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Spain
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Aravaca
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Boadilla Del Monte Madrid
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Spain
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Burgos
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Spain
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Getafe
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Marbella
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Spain
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Sevilla
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Spain
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TorrejOn Ardoz Madrid
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Spain
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Valencia
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Spain
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Valladolid
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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ChiangMai
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United Kingdom
State/province [108] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04605159