Last updated: 07/14/2025 07:13:41

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
EudraCT ID
2022-003124-41
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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 is 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 will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting pregnancy related adverse events of special interest (AESIs) from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination

Secondary outcomes:

Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting pregnancy related AESIs from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination

Timeframe: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination

Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination

Timeframe: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination

Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination

Timeframe: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination

Interventions:
  • Biological/vaccine: RSVPreF3 vaccine
  • Other: Control
    • Enrollment:
    3962
    Primary completion date:
    2025-15-01
    Observational study model:
    Not applicable
    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
    Nampa, ID, United States, 83686
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Grafton Auckland, New Zealand, 1010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Papatoetoe Auckland, New Zealand, 1701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buenos Aires, Argentina, 1425
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cali Colombia, Colombia, 760042
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Panama, Panama, 0801
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 145 Results

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    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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