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Not Yet Recruiting NCT05705440

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

Conditions: Respiratory Syncytial Virus Infections

Sex: Female
Ages: 9 Years – 49 Years
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 4129
Sponsor: GlaxoSmithKline

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.

Eligibility Criteria

Inclusion Criteria:Retrospective cohortAdult/Adolescent Participant: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).Study participant:who has reached 2 years+2 months post vaccine/control prior to/at enrolment orwho 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 cohortAdult/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).Study participant:who has not reached 2 years+2 months post vaccine/control prior to/at enrollment orwho 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 potentialProvide 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 studyParticipant's parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocolSigned 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05705440). StuddyBuddy aggregates publicly available trial information.