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
Study Details
Study Description
Brief Summary
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 previous RSV MAT primary study.
The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following RSV MAT primary 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 previous RSV MAT studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: RSVPreF3 Group Participants received the RSVPreF3 vaccine during the RSV MAT primary studies (RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. |
Biological: RSVPreF3 vaccine
No intervention is administered in this extension study. Participants received the RSVPreF3 vaccine during the RSV MAT primary 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 RSV MAT primary studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.
|
| Other: Control Group Participants received any control (placebo, Tdap or influenza vaccine) during the RSV MAT primary studies (RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. |
Other: Control
No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the RSV MAT primary 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 RSV MAT primary studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).
|
Outcome Measures
Primary Outcome Measures
- Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination [From Day 1 up to Day 42 post-delivery of the first pregnancy conceived 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 post-vaccination [From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination]
- Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination [From birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination]
Secondary Outcome Measures
- Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination [From Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination]
- Percentage of maternal participants reporting pregnancy related AESIs from Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination [From Day 1 up to Day 42 post-delivery of any pregnancy conceived post-vaccination]
- Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived post-vaccination [From birth up to Day 42 post-birth of any pregnancy conceived 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 post-vaccination [From Day 1 up to Day 42 post-delivery of any pregnancy conceived 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 post-vaccination [From Day 1 up to Day 42 post-delivery of any pregnancy conceived 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 post-vaccination [From birth up to Day 42 post-birth of any pregnancy conceived 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 post-vaccination [From Day 1 up to Day 42 post-delivery of the first pregnancy conceived 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 post-vaccination [From Day 1 up to Day 42 post-delivery of the first pregnancy conceived 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 post-vaccination [From birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
Retrospective cohort
Adult/Adolescent Participant:
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Adult/Adolescent study participant, from RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 or RSV MAT-039 studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
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Study participant:
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who has reached 2 years+2 months post vaccine/control prior to/at enrolment or
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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.
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Study participant with any pregnancy conceived post vaccination/control, that has reached Day 42 post-delivery prior to/at enrollment.
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Provide signed and dated informed consent form.
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Be willing to comply with all study requirements and be available for the duration of the study.
Infant Participant:
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Participant live born as the result of a pregnancy followed in an adult/adolescent participant in this study.
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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 RSV-MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 or RSV MAT-039 studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
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Study participant:
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who has not reached 2 years+2 months post vaccine/control prior to/at enrollment or
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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.
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Female participants of childbearing potential
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Provide signed and dated informed consent form.
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Be willing to comply with all study procedures and be available for the duration of the study.
Infant Participant:
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Participant live born as the result of a pregnancy followed in an adolescent/adult participant in this study
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Participant's parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol
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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.
Infant participant:
• Child in care
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 219510
- 2022-003124-41