A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

NCT05705440
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Phase
Phase 3
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Recruitment status
Completed
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Participants
3,855
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Lead sponsor
GlaxoSmithKline
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Start date
2023-02-07
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Number of sites
138
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Summary
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.
clinicaltrials.gov
Short title
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
clinicaltrials.gov
Official title
A Phase 3b, Non-randomized, Open Label, Multi-country, Cohort Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous 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) During Any Pregnancy Conceived Post Vaccination/Control
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Control arm
Open label
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-01-15
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First posted
2023-01-30
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Registry last updated
2026-03-17
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Primary completion date
2025-01-15
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Start date
2023-02-07
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Actual participants
3,855
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Participants
3,855
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
138
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05705440
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ClinicalTrials.gov ID
NCT05705440
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Other
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. 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

    Timeframe: 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.

  2. 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

    Timeframe: 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.

  3. 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

    Timeframe: 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.

  1. 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

    Timeframe: From conception until Day 42 post-delivery of any 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; 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.

  2. 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

    Timeframe: From conception until Day 42 post-delivery of any pregnancy conceived 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.

  3. 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

    Timeframe: 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.

  4. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any 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. 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.

  5. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any 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. 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.

  6. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any pregnancy conceived 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.

  7. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any 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. 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.

  8. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any pregnancy conceived 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.

  9. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any 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. 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.

  10. 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

    Timeframe: From Day 1 until Day 42 post-delivery of any pregnancy conceived 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.

  11. 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

    Timeframe: 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.

  12. 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

    Timeframe: 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.

  13. 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

    Timeframe: 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).

  14. 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

    Timeframe: 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.

  15. 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

    Timeframe: 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.

  16. 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

    Timeframe: 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.

  17. 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Children, Adults
Minimum age
9 Years
Maximum age
49 Years
Healthy volunteers
Yes

Retrospective cohort

Adult/Adolescent Participant:

  • Adult/Adolescent study participant from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).

  • Study participant:

    • who has reached 2 years+2 months post vaccine/control prior to/at enrolment or
    • who has not reached 2 years+2 months post vaccine/control prior to/at enrolment but is a Woman of Nonchildbearing Potential (WONCBP) at study enrolment, or recipient of bilateral tubal ligation prior to study enrolment.

  • Study participant with any pregnancy conceived post vaccination/control, that has reached Day 42 post-delivery prior to/at enrollment.

  • Provide signed and dated informed consent form.

  • Be willing to comply with all study requirements and be available for the duration of the study.

Infant Participant:

  • Participant live born as the result of a pregnancy followed in an adult/adolescent participant in this study.
  • Signed and dated informed consent form obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.

Prospective cohort

Adult/Adolescent Participant:

  • Adult/adolescent study participant from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).

  • Study participant:

    • who has not reached 2 years+2 months post vaccine/control prior to/at enrollment or
    • who has reached at least 2 years+2 months post vaccine/control but has an ongoing pregnancy (prior to Day 42 post-delivery) at enrollment. Participants who have reached 2 years post-vaccine/control before enrollment but are pregnant at enrollment will be enrolled and followed until Day 42 post-delivery for the pregnancy ongoing at enrollment.

  • Female participants of childbearing potential.

  • Provide signed and dated informed consent form.

  • Be willing to comply with all study procedures and be available for the duration of the study.

Infant Participant:

  • Participant live born as the result of a pregnancy followed in an adolescent/adult participant in this study.
  • Participant's parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Signed and dated informed consent form obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.

Adult/adolescent participant otherwise eligible for the prospective cohort:

• Woman of Nonchildbearing Potential (WONCBP) at study enrollment, or recipient of bilateral tubal ligation prior to study enrollment, if she has not conceived a pregnancy post-vaccine/control and does not plan to use any additional measures to attempt to conceive a pregnancy (e.g., sterilization reversal or IVF).

Infant participant:

• Child in care.

Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteMobile, United States
  • GSK Investigational SitePhoenix, United States
  • GSK Investigational SiteTucson, United States
  • GSK Investigational SiteBurbank, United States
  • GSK Investigational SiteLos Angeles, United States
  • GSK Investigational SiteNampa, United States
  • GSK Investigational SiteNampa, United States
  • GSK Investigational SiteCovington, United States
  • GSK Investigational SiteSlidell, United States
  • GSK Investigational SiteDetroit, United States
  • GSK Investigational SiteSaginaw, United States
  • GSK Investigational SiteBiloxi, United States
  • GSK Investigational SiteAlbuquerque, United States
  • GSK Investigational SiteEnglewood, United States
  • GSK Investigational SiteGreenville, United States
  • GSK Investigational SiteHendersonville, United States
  • GSK Investigational SiteAustin, United States
  • GSK Investigational SiteFort Worth, United States
  • GSK Investigational SiteHouston, United States
  • GSK Investigational SiteKeller, United States
  • GSK Investigational SiteKeller, United States
  • GSK Investigational SiteKeller, United States
  • GSK Investigational SiteLampasas, United States
  • GSK Investigational SitePlano, United States
  • GSK Investigational SiteWeatherford, United States

And 113 more, listed on the interactive page.

Sources for sites
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Other registry identifiers

  • 2022-003124-41
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)