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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Virus Infections

Treatments: Other: Control; Biological: RSVPreF3 vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05705440

2022-003124-41 (EudraCT Number)

219510

Details and patient eligibility

About

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.

Enrollment: 3,962 patients

Sex: Female

Ages: 9 to 49 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,962 participants in 2 patient groups

RSVPreF3 Group

Other group

Description:

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.

Treatment:

Biological: RSVPreF3 vaccine

Control Group

Other group

Description:

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.

Treatment:

Other: Control