A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vac… (NCT05705440) | Clinical Trial Compass
CompletedPhase 3
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
United States, Argentina, Australia3,855 participantsStarted 2023-02-07
Plain-language 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.
Who can participate
Age range
9 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
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
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