Clinical Trial Results:
A Phase III, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal vaccine, in high risk pregnant women aged 15 to 49 years and infants born to the vaccinated mothers
Summary
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EudraCT number |
2021-000994-96 |
Trial protocol |
FI ES IT Outside EU/EEA |
Global end of trial date |
30 May 2023
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Results information
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Results version number |
v1 |
This version publication date |
14 Dec 2023
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First version publication date |
14 Dec 2023
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Other versions |
v2 , v3 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
214725
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04980391 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002821-PIP01-20 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Oct 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 May 2023
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
• To evaluate the safety and reactogenicity of a single IM dose of study intervention administered to maternal participants up to 42 days post-delivery.
• To evaluate the pregnancy outcomes and pregnancy-related AESIs up to 42 days post-delivery, in maternal participants who received a single IM dose of study intervention.
• To evaluate safety up to 42 days post-birth in infants born to maternal participants who received a single IM dose of study intervention.
• To evaluate the safety of the vaccine in infants up to 365 days post-birth.
• To evaluate the immunogenicity of a single IM dose of study intervention administered to maternal participants, at delivery.
• To evaluate the transfer of RSV-specific antibodies from maternal participants who received a single IM dose of study intervention to their infants at delivery.
• To evaluate the RSV-specific antibody levels at birth in infants born to maternal participants who received a single IM dose of study intervention.
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Protection of trial subjects |
Maternal participants remained under observation for 30 minutes after the administration of the study intervention to ensure that immediate treatment would be provided in the event of a hypersensitivity reaction, or syncope.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Brazil: 21
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Country: Number of subjects enrolled |
Canada: 15
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Country: Number of subjects enrolled |
Finland: 15
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Country: Number of subjects enrolled |
India: 7
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Country: Number of subjects enrolled |
Italy: 5
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Country: Number of subjects enrolled |
Panama: 63
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Country: Number of subjects enrolled |
South Africa: 94
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Country: Number of subjects enrolled |
Spain: 81
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Country: Number of subjects enrolled |
United States: 83
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Worldwide total number of subjects |
384
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EEA total number of subjects |
101
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
37
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Newborns (0-27 days) |
161
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
20
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Adults (18-64 years) |
166
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed. | |||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
The study was originally double-blinded, but due to a safety signal, it was fully unblinded to ensure the safety monitoring of the participants.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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RSV_MAT Group-Mother | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
RSV MAT
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
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Arm title
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Control Group-Mother | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose of Placebo, administered intramuscularly in the non-dominant arm, at Day 1.
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Arm title
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RSV_MAT Group-Infant | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Control Group-Infant | |||||||||||||||||||||||||||||||||||||||||||||
Arm description |
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. | |||||||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | |||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed. |
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Baseline characteristics reporting groups
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Reporting group title |
RSV_MAT Group-Mother
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Reporting group description |
Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group-Mother
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Reporting group description |
Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RSV_MAT Group-Infant
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Reporting group description |
This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group-Infant
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Reporting group description |
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
RSV_MAT Group-Mother
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Reporting group description |
Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||
Reporting group title |
Control Group-Mother
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Reporting group description |
Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||
Reporting group title |
RSV_MAT Group-Infant
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Reporting group description |
This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. | ||
Reporting group title |
Control Group-Infant
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Reporting group description |
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. | ||
Subject analysis set title |
RSV_MAT Group
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
This group consisted of pairs of maternal participants from RSV_MAT Group - Mother and infant participants from RSV_MAT Group - Infant.
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Subject analysis set title |
Control Group
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
This group consisted of pairs of maternal participants from Control Group - Mother and infant participants from Control Group - Infant.
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End point title |
Percentage of maternal participants reporting any solicited administration site events [1] [2] | |||||||||||||||||||||
End point description |
Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
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End point type |
Primary
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End point timeframe |
From Day 1 to Day 7 included
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting any solicited systemic events [3] [4] | |||||||||||||||||||||||||||||||||
End point description |
Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
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End point type |
Primary
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End point timeframe |
From Day 1 to Day 7 included
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting any unsolicited adverse events (AEs) [5] [6] | ||||||||||||
End point description |
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 to Day 30 included
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery [7] [8] | ||||||||||||
End point description |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery [9] [10] | |||||||||
End point description |
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) and live births with at least 1 major congenital anomaly [11] [12] | |||||||||||||||||||||
End point description |
The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/legally acceptable representatives (LARs) completed the informed consent process and signed the informed consent form.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery [13] [14] | ||||||||||||
End point description |
An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery [15] [16] | |||||||||||||||||||||||||||||||||
End point description |
Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery [17] [18] | |||||||||||||||||||||
End point description |
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria:
- Change in medication and/or medication dose.
- Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication.
- SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
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End point type |
Primary
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End point timeframe |
From Day 1 up to 42 days post-delivery
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Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
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No statistical analyses for this end point |
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End point title |
Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth [19] [20] | |||||||||||||||||||||||||||||||||
End point description |
Neonatal/infant AESIs included low birth weight (below [<] 2500 grams), very low birth weight (<1500 grams), extremely low birth weight (<1000 grams), preterm birth (<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above [>=] 28 and <37 weeks). Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
|||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
From birth up to 42 days post-birth
|
|||||||||||||||||||||||||||||||||
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth [21] [22] | ||||||||||||
End point description |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 180 days post-birth
|
||||||||||||
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting MAEs from birth up to 42 days post-birth [23] [24] | ||||||||||||
End point description |
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 42 days post-birth
|
||||||||||||
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth [25] [26] | |||||||||
End point description |
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From birth up to 42 days post-birth
|
|||||||||
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth [27] [28] | ||||||||||||
End point description |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 42 days post-birth
|
||||||||||||
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth [29] [30] | |||||||||
End point description |
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From birth up to 365 days post-birth
|
|||||||||
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth [31] [32] | ||||||||||||
End point description |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 365 days post-birth
|
||||||||||||
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting MAEs from birth up to 180 days post-birth [33] [34] | ||||||||||||
End point description |
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 180 days post-birth
|
||||||||||||
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting MAEs from birth up to 365 days post-birth [35] [36] | ||||||||||||
End point description |
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From birth up to 365 days post-birth
|
||||||||||||
Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth [37] [38] | |||||||||
End point description |
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
From birth up to 180 days post-birth
|
|||||||||
Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1) [39] [40] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At pre-dosing (Day 1)
|
||||||||||||
Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for maternal participants at delivery [41] [42] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At delivery
|
||||||||||||
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1) [43] [44] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At pre-dosing (Day 1)
|
||||||||||||
Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for maternal participants at delivery [45] [46] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At delivery
|
||||||||||||
Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations [47] | ||||||||||||
End point description |
The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth [if no cord blood could be obtained]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery). Analysis was performed on all pairs of maternal participants (from Per Protocol Set Immunogenicity - Maternal) and their infants (from Per Protocol Set Immunogenicity - Infant) with available results for this outcome measure at the specified time points.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At delivery (for maternal participants) or within 72 hours after birth (for infant participants)
|
||||||||||||
Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth [48] [49] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At delivery or within 72 hours after birth
|
||||||||||||
Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth [50] [51] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) have protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
At delivery or within 72 hours after birth
|
||||||||||||
Notes [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery [52] | ||||||||||||
End point description |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 1 up to 180 days post-delivery
|
||||||||||||
Notes [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery [53] | |||||||||
End point description |
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From Day 1 up to 180 days post-delivery
|
|||||||||
Notes [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery [54] | ||||||||||||
End point description |
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 1 up to 180 days post-delivery
|
||||||||||||
Notes [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||
End point title |
Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery [55] | |||||||||
End point description |
RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From Day 1 up to 180 days post-delivery
|
|||||||||
Notes [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
||||||||||
|
||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery [56] | |||||||||||||||||||||
End point description |
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgement and the following criteria:
- Change in medication and/or medication dose.
- Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication.
- SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
From Day 1 up to 180 days post-delivery
|
|||||||||||||||||||||
Notes [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth [57] | ||||||||||||
End point description |
RSV-associated hospitalization was defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization was defined as admission for observation or treatment based on the judgment of a health care provider.
Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From birth up to 365 days post-birth
|
||||||||||||
Notes [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Percentage of infant participants reporting medically assessed, RSV-associated lower respiratory tract illness (LRTIs) of any severity and RSV-associated severe LRTIs from birth up to 365 days post-birth [58] | ||||||||||||||||||
End point description |
An RSV-associated LRTI is characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI meets the case definition of RSV-LRTI AND is additionally characterized by a SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious.
Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
From birth up to 365 days post-birth
|
||||||||||||||||||
Notes [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing [59] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 31 post-dosing
|
||||||||||||
Notes [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for maternal participants at Day 31 post-dosing [60] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 31 post-dosing
|
||||||||||||
Notes [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery [61] | |||||||||||||||||||||
End point description |
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time points, minus those participants with protocol deviations that lead to exclusion.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At pre-dosing (Day 1), Day 31 post-dosing and delivery
|
|||||||||||||||||||||
Notes [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for maternal participants. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-B neutralizing titers for infant participants at delivery or within 72 hours after birth [62] | ||||||||||||
End point description |
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At delivery or within 72 hours after birth
|
||||||||||||
Notes [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for infant participants at Day 43 post-birth [63] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 43 post-birth
|
||||||||||||
Notes [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for infant participants at Day 121 post-birth [64] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 121 post-birth
|
||||||||||||
Notes [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV MAT IgG-specific antibody concentrations for infant participants at Day 181 post-birth [65] | ||||||||||||
End point description |
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "241".
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 181 post-birth
|
||||||||||||
Notes [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for infant participants at Day 43 post-birth [66] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 43 post-birth
|
||||||||||||
Notes [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for infant participants at Day 181 post-birth [67] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "115".
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 181 post-birth
|
||||||||||||
Notes [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-A neutralizing titers for infant participants at Day 121 post-birth [68] | ||||||||||||
End point description |
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 121 post-birth
|
||||||||||||
Notes [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-B neutralizing titers for infant participants at Day 121 post-birth [69] | ||||||||||||
End point description |
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 121 post-birth
|
||||||||||||
Notes [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-B neutralizing titers for infant participants at Day 43 post-birth [70] | ||||||||||||
End point description |
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 43 post-birth
|
||||||||||||
Notes [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
RSV-B neutralizing titers for infant participants at Day 181 post-birth [71] | ||||||||||||
End point description |
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "63".
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 181 post-birth
|
||||||||||||
Notes [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the infants born to maternal participants. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Maternal groups: Solicited AEs - from Day 1 to Day 7 (included) and Unsolicited AEs - from Day 1 to Day 30 (included) after vaccination. SAEs - from Day 1 up to 180 days post-delivery. Infant groups: SAEs - from birth up to 365 days post-birth.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post-vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in this study.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
|
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Reporting groups
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Reporting group title |
RSV_MAT Group-Mother
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Reporting group description |
Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group-Infant
|
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Reporting group description |
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
RSV_MAT Group-Infant
|
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Reporting group description |
This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group-Mother
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Reporting group description |
Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
15 Mar 2022 |
Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing participants at that time continued to be monitored as part of the study. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |