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

August 30, 2023 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425EFD
      • Rio Cuarto, Argentina, 5800
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1425
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Doreski
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
      • Southport, Queensland, Australia, 4215
    • Victoria
      • Clayton, Victoria, Australia, 3168
  • Bangladesh
      • Dhaka, Bangladesh
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Khalequ Zaman
      • Sylhet, Bangladesh, 3100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Khalequ Zaman
  • Belgium
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Sint-Niklaas, Belgium, 9100
  • Brazil
      • Alto Da Posse, Nova Iguacu, Brazil, 26030-380
    • Rio Grande Do Sul
      • Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035001
      • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
  • Canada
      • Quebec, Canada, G1W 4R4
      • Québec, Canada, G1V 4G2
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 2N6
      • Vancouver, British Columbia, Canada, V6Z 2T1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
      • Truro, Nova Scotia, Canada, B2N 1L2
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N5W 6A2
      • Sarnia, Ontario, Canada, N7T 4X3
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
      • Montreal, Quebec, Canada, H3T 1C5
      • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
      • Sherbrooke, Quebec, Canada, J1L 0H8
  • Colombia
      • Barranquilla, Colombia, 760002
      • Cali, Colombia, 760042
      • Chía, Colombia, 250001
      • Medellin, Colombia, 050034
  • Dominican Republic
      • Santo Domingo, Dominican Republic
  • Finland
      • Espoo, Finland, 02230
      • Helsinki, Finland, 00100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susanna Koski
      • Helsinki, Finland, 00930
      • Helsinki, Finland, 00290
      • Jarvenpaa, Finland, 04400
      • Kokkola, Finland, 67100
      • Oulu, Finland, 90220
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satu Kokko
      • Pori, Finland, 28100
      • Seinajoki, Finland, 60100
      • Tampere, Finland, 33100
      • Turku, Finland, 20520
  • France
      • Bordeaux, France, 33000
      • Bron, France, 69500
      • Paris, France, 75679
  • Germany
      • Hamburg, Germany, 22143
    • Bayern
      • Wuerzburg, Bayern, Germany, 97070
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tino F Schwarz
        • Contact:
        • Contact:
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
    • Nordrhein-Westfalen
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thorsten Krause
        • Contact:
        • Contact:
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefan Regner
  • Honduras
      • Comayagua, Honduras
      • San Pedro Sula, Honduras, 21101
  • India
      • Kolkata, India, 700017
      • Mangalore, India, 575001
      • Mysuru, India, 570015
      • Nagpur, India, 441108
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuchita Mundle
      • Pune, India, 411043
    • Maharashtra
      • Pune, Maharashtra, India, 412216
  • Italy
      • Verona, Italy, 37126
    • Lombardia
      • Milano, Lombardia, Italy, 20154
    • Puglia
      • Bari, Puglia, Italy, 70124
    • Sicilia
      • Messina, Sicilia, Italy, 98124
    • Toscana
      • Prato, Toscana, Italy, 59100
  • Korea, Republic of
      • Ansan, Korea, Republic of, 425-707
      • Seoul, Korea, Republic of, 08308
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of, ?08308
  • Mexico
      • Oaxaca, Mexico, 68000
    • Nuevo León
      • Mitras Centro, Nuevo León, Mexico, 64460
    • Querétaro
      • San Juan del Río, Querétaro, Mexico, 76800
  • New Zealand
      • Auckland, New Zealand, 1010
      • Auckland, New Zealand, 1701
      • Newtown, Wellington, New Zealand, 6002
  • Panama
      • Ciudad de Panama, Panama, 7099
      • La Chorrera, Panama, 07079
      • Panama, Panama, 0801
      • Panama, Panama, 1001
  • Philippines
      • Manila, Philippines, 1000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ricardo Jr Manalastas
      • Manila, Philippines, 1008
  • South Africa
      • Soshanguve, South Africa, 0152
    • Gauteng
      • Coronationville, Gauteng, South Africa, 2112
      • Pretoria, Gauteng, South Africa, 0184
      • Soweto, Gauteng, South Africa, 2013
  • Spain
      • Aravaca, Spain, 28023
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xavier Martinez Gomez
        • Contact:
        • Contact:
      • Bilbao, Spain, 48013
      • Burgos, Spain, 09006
      • Gandía (Valencia), Spain, 46702
      • Getafe/Madrid, Spain, 28905
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28006
      • Majadahonda (Madrid), Spain, 28222
      • Malaga, Spain, 29010
      • Marbella, Spain, 29603
      • Santiago de Compostela, Spain, 15706
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41014
      • Torrejón Ardoz, Spain, 28850
      • Valencia, Spain, 46017
      • Valencia, Spain, 46020
      • Valladolid, Spain, 47012
    • Andalucia
      • Malaga, Andalucia, Spain, 29004
    • Madrid
      • Boadilla del Monte, Madrid, Spain, 28660
      • Collado Villalba, Madrid, Spain, 28400
  • Taiwan
      • Taichung, Taiwan, 40447
      • Taipei, Taiwan, 0105
      • Taipei, Taiwan, 10041
      • Taoyuan, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10330
      • Muang, Thailand, 50200
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85015
      • Tucson, Arizona, United States, 85712
    • California
      • Burbank, California, United States, 91506
      • Los Angeles, California, United States, 90057
    • Florida
      • West Palm Beach, Florida, United States, 33409
    • Idaho
      • Nampa, Idaho, United States, 83686
      • Nampa, Idaho, United States, 83687
    • Louisiana
      • Covington, Louisiana, United States, 70433
      • Slidell, Louisiana, United States, 70458
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Saginaw, Michigan, United States, 48604
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
    • New York
      • Vestal, New York, United States, 13850
    • North Carolina
      • Hendersonville, North Carolina, United States, 28792
    • Ohio
      • Englewood, Ohio, United States, 45322
    • South Carolina
      • Greenville, South Carolina, United States, 29607
    • Texas
      • Arlington, Texas, United States, 75050
      • Austin, Texas, United States, 78705
      • Burleson, Texas, United States, 76028
      • Fort Worth, Texas, United States, 76104
      • Georgetown, Texas, United States, 78626
      • Houston, Texas, United States, 77008
      • Keller, Texas, United States, 76248
      • Lampasas, Texas, United States, 76550
      • Plano, Texas, United States, 75093
      • Weatherford, Texas, United States, 76086
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: 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: 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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Estimated)

February 5, 2025

Study Completion (Estimated)

February 5, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219510
  • 2022-003124-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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