The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention was administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the abovementioned prior RSV MAT studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3,855
No intervention was administered in this extension study. Participants received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.
No intervention was administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Burbank, California, United States
GSK Investigational Site
Los Angeles, California, United States
Number of Maternal Participants With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed pregnancy outcomes were live infant with no apparent congenital anomaly; spontaneous abortion with no apparent congenital anomaly; ectopic pregnancy; elective termination with no apparent congenital anomaly; live infant with congenital anomaly, and stillbirth with congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.
Time frame: From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed pregnancy-related AESIs were chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, premature preterm ruptures of membranes, preterm labor and provider-initiated preterm birth. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.
Time frame: From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed AESIs were congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, low birth weight \[greater than or equal to (\>=) 1500 grams (G) and below (\<) 2500 G\], very low birth weight (\>=1000 G and \<1500 G), neonatal death in a term live birth (\>=37 weeks of gestational age), preterm birth (\<37 weeks of gestational age) and small for gestational age.
Time frame: From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed pregnancy outcomes were live infant with no apparent congenital anomaly; spontaneous abortion with no apparent congenital anomaly; ectopic pregnancy; elective termination with no apparent congenital anomaly; live infant with congenital anomaly; molar pregnancy; stillbirth with congenital anomaly and stillbirth with no apparent congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, pregnancy outcomes were calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Pregnancy-related AESIs From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed pregnancy-related AESIs were preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, gestational diabetes mellitus, gestational hypertension, pre-eclampsia with severe features including eclampsia, pre-eclampsia, fetal growth restriction and chorioamnionitis. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, pregnancy-related AESIs were calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of Any Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
Assessed AESIs were congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, low birth weight (\>=1500 G and \<2500 G), very low birth weight (\>=1000 G and \<1500 G), neonatal death in a term live birth (\>=37 weeks of gestational age), preterm birth (\<37 weeks of gestational age) and small for gestational age.
Time frame: From birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
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GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Covington, Louisiana, United States
GSK Investigational Site
Slidell, Louisiana, United States
GSK Investigational Site
Detroit, Michigan, United States
...and 128 more locations
Number of Pregnancies With Preterm Birth Event Data Stratified by Selected Risk Factors, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. The below presented data is read as follows: Yes = the respective risk factor was experienced by the maternal participant in the past and/or during pregnancy. No = the respective risk factor was not experienced by the maternal participant in the past and/or during pregnancy. With preterm birth event = the assessed pregnancy resulted in a preterm birth event. Without preterm birth event = the assessed pregnancy did not result in a preterm birth event. As pre-specified in the SAP, preterm birth event data stratified by selected risk factors was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Age Group at Vaccination, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The age groups at vaccination assessed were \<18 years, 18-24 years, 25-34 years and \>=35 years. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by age group at vaccination was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Pre-pregnancy BMI, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The pre-pregnancy body mass index (BMI) categories assessed were \< 30 kilogram per square meter (kg/m\^2), \>=30 kg/m\^2 and missing (no pre-pregnancy BMI data available). Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by pre-pregnancy BMI was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Race, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by race was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Multiple Gestation Pregnancy, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The multiple gestation pregnancies assessed were one gestation, two gestations and three gestations. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by multiple gestation pregnancy was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Geographic Region, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by geographic region was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Pregnancies With Preterm Birth Event Data Stratified by Economic Region, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The economic regions assessed were low and middle-income countries (LMIC) and high-income countries (HIC). Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by economic region was calculated based on the number of pregnancies observed from the maternal participants.
Time frame: From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Selected Risk Factors, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. The below presented data is read as follows: Yes = the respective risk factor was experienced by the maternal participant in the past and/or during pregnancy. No = the respective risk factor was not experienced by the maternal participant in the past and/or during pregnancy. With preterm birth event = the assessed pregnancy resulted in a preterm birth event. Without preterm birth event = the assessed pregnancy did not result in a preterm birth event.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Age Group at Vaccination, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The age groups at vaccination assessed were \<18 years, 18-24 years, 25-34 years and \>=35 years.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Pre-pregnancy BMI Group, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The pre-pregnancy BMI categories assessed were \< 30 kilogram per square meter (kg/m\^2), \>=30 kg/m\^2 and missing (no pre-pregnancy BMI data available).
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Race, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Multiple Gestation Pregnancy, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The multiple gestation pregnancies assessed were one gestation and two gestations.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Geographic Region, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Number of Maternal Participants With Preterm Birth Event Data Stratified by Economic Region, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
The economic regions assessed were LMIC and HIC.
Time frame: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies