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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05705440
Registration number
NCT05705440
Ethics application status
Date submitted
20/01/2023
Date registered
30/01/2023
Date last updated
1/09/2023
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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2022-003124-41
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Secondary ID [2]
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219510
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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0
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Condition category
Condition code
Respiratory
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0
0
0
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Other respiratory disorders / diseases
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Infection
0
0
0
0
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Other infectious diseases
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Infection
0
0
0
0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSVPreF3 vaccine
Other interventions - Control
Other: RSVPreF3 Group - 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.
Other: Control Group - 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 interventions: RSVPreF3 vaccine
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.
Other interventions: Control
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).
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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Primary outcome [2]
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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
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Assessment method [2]
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0
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Timepoint [2]
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From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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Primary outcome [3]
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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
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Assessment method [3]
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0
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Timepoint [3]
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From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
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Secondary outcome [1]
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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
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Assessment method [1]
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0
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Timepoint [1]
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From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [2]
0
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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
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Assessment method [2]
0
0
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Timepoint [2]
0
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From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [3]
0
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Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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Assessment method [3]
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0
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Timepoint [3]
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From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [4]
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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
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Assessment method [4]
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0
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Timepoint [4]
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From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [5]
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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
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Assessment method [5]
0
0
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Timepoint [5]
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From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [6]
0
0
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
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Assessment method [6]
0
0
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Timepoint [6]
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0
From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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Secondary outcome [7]
0
0
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
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Assessment method [7]
0
0
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Timepoint [7]
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From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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Secondary outcome [8]
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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
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Assessment method [8]
0
0
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Timepoint [8]
0
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From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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Secondary outcome [9]
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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
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Assessment method [9]
0
0
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Timepoint [9]
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From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
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Eligibility
Key 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.
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Minimum age
9
Years
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Maximum age
49
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/02/2025
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Actual
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Sample size
Target
4129
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - South Brisbane
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Recruitment hospital [2]
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GSK Investigational Site - Southport
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Recruitment hospital [3]
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GSK Investigational Site - Clayton
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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4215 - Southport
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
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Alabama
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Idaho
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Louisiana
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Mississippi
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Nebraska
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Pori
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Korea, Republic of
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Ansan
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Ciudad de Panama
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Majadahonda (Madrid)
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Torrejón Ardoz
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Valencia
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Valladolid
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Muang
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Funding & Sponsors
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Commercial sector/Industry
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GlaxoSmithKline
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Summary
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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05705440
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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US GSK Clinical Trials Call Center
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877-379-3718
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05705440
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