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.

Phase 1

• Conditions: Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants; MedDRA version: 20.0Level: PTClassification code 10070538Term: Gestational hypertensionSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 25.0Level: LLTClassification code 10086971Term: Pre-eclampsia with severe featuresSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: LLTClassification code 10070532Term: Fetal growth restrictionSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10073024Term: Preterm premature rupture of membranesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 21.1Level: LLTClassification code 10075863Term: Preterm laborSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 21.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: LLTClassification code 10008755Term: ChorioamnionitisSystem Organ Class: 100000004862; MedDRA version: 21.1Level: LLTClassification code 10041093Term: Small for gestational ageSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

• Registration Number: EUCTR2022-003124-41-BE
• Lead Sponsor: GlaxoSmithKline Biologicals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 4187

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified