Last updated: 03/17/2026 12:10:35

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

GSK study ID
219510
See study documents
Clinicaltrials.gov ID
NCT05705440
See results summary
EudraCT ID
2022-003124-41
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

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

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

Secondary outcomes:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Interventions:
Biological/vaccine: RSVPreF3 vaccine
Other: Control
Enrollment:
3855
Observational study model:
Not applicable
Primary completion date:
2025-15-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2023 to January 2025
Type
Interventional
Phase
3

Participation criteria

Sex
Female
Age
9 - 49 Years
Accepts healthy volunteers
Yes
  • Retrospective cohort
  • Adult/Adolescent Participant:
  • 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).
Inclusion and exclusion criteria
Inclusion criteria:

    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.
Exclusion criteria:

    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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Pune, India, 411043
4.6 miles (7.4 km) away from your location
Status
Study Complete
Contact us
Location
GSK Investigational Site
Vadu Budruk Pune, India, 412216
14.4 miles (23.0 km) away from your location
Status
Study Complete
Contact us

Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2025-15-01
Actual study completion date
2025-15-01

Plain language summaries

Summary of results in plain language
Available language(s): English, Bangladeshi Bangla (Bangladesh), Bengali, Dutch (Belgium), Finnish, French (Belgium), French (Canadian), French, German, Hindi, Italian, Kannada, Korean, Malayalam, Marathi, Portuguese (Brazil), Spanish (Argentina), Spanish (Columbia), Spanish (Dominican Republic), Spanish (Honduras), Spanish (Panama), Spanish, Spanish (United States), Swedish (Finland), Tagalog, Thai, Chinese (Traditional), Zulu
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To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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