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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Biological: RSVPreF3 vaccine
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RSVPreF3 Group<br>Participants received the RSVPreF3 vaccine during the prior RSV MAT 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<br>* No intervention is administered in this extension study. Participants received the RSVPreF3 vaccine during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.<br>|
| Other: Control Group<br>Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT 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<br>* No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pregnancy, RSVPreF3 vaccine, Follow-up study, Retrospective data, Prospective data