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

Respiratory Syncytial Virus Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705440
• Other study ID #: 219510
• Secondary ID: 2022-003124-41
• Status: Recruiting
• Phase: Phase 3
• Start date: February 7, 2023
• Est. completion date: February 5, 2025

Study information

• Verified date: August 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4129
• Est. completion date: February 5, 2025
• Est. primary completion date: February 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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
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).

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Caba	Buenos Aires
Argentina	GSK Investigational Site	Rio Cuarto
Australia	GSK Investigational Site	Clayton	Victoria
Australia	GSK Investigational Site	South Brisbane	Queensland
Australia	GSK Investigational Site	Southport	Queensland
Bangladesh	GSK Investigational Site	Dhaka
Bangladesh	GSK Investigational Site	Sylhet
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Sint-Niklaas
Brazil	GSK Investigational Site	Alto Da Posse, Nova Iguacu
Brazil	GSK Investigational Site	Caxias do Sul	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Ribeirão Preto	São Paulo
Brazil	GSK Investigational Site	Santa Maria	Rio Grande Do Sul
Brazil	GSK Investigational Site	Sao Jose do Rio Preto	São Paulo
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Mirabel	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Saint-Charles-Borromée	Quebec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Colombia	GSK Investigational Site	Barranquilla
Colombia	GSK Investigational Site	Cali
Colombia	GSK Investigational Site	Chía
Colombia	GSK Investigational Site	Medellin
Dominican Republic	GSK Investigational Site	Santo Domingo
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kokkola
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Bron
France	GSK Investigational Site	Paris
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Wuerzburg	Bayern
Honduras	GSK Investigational Site	Comayagua
Honduras	GSK Investigational Site	San Pedro Sula
India	GSK Investigational Site	Kolkata
India	GSK Investigational Site	Mangalore
India	GSK Investigational Site	Mysuru
India	GSK Investigational Site	Nagpur
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Pune	Maharashtra
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Messina	Sicilia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Prato	Toscana
Italy	GSK Investigational Site	Verona
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Mexico	GSK Investigational Site	Mitras Centro	Nuevo León
Mexico	GSK Investigational Site	Oaxaca
Mexico	GSK Investigational Site	San Juan del Río	Querétaro
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Newtown, Wellington
Panama	GSK Investigational Site	Ciudad de Panama
Panama	GSK Investigational Site	La Chorrera
Panama	GSK Investigational Site	Panama
Panama	GSK Investigational Site	Panama
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Manila
South Africa	GSK Investigational Site	Coronationville	Gauteng
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Soshanguve
South Africa	GSK Investigational Site	Soweto	Gauteng
Spain	GSK Investigational Site	Aravaca
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Boadilla del Monte	Madrid
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Collado Villalba	Madrid
Spain	GSK Investigational Site	Gandía (Valencia)
Spain	GSK Investigational Site	Getafe/Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Malaga	Andalucia
Spain	GSK Investigational Site	Marbella
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Torrejón Ardoz
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Muang
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Biloxi	Mississippi
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Burleson	Texas
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Englewood	Ohio
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Georgetown	Texas
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Hendersonville	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Keller	Texas
United States	GSK Investigational Site	Lampasas	Texas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Nampa	Idaho
United States	GSK Investigational Site	Nampa	Idaho
United States	GSK Investigational Site	Norfolk	Nebraska
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Saginaw	Michigan
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Vestal	New York
United States	GSK Investigational Site	Weatherford	Texas
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bangladesh,  Belgium,  Brazil,  Canada,  Colombia,  Dominican Republic,  Finland,  France,  Germany,  Honduras,  India,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Panama,  Philippines,  South Africa,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Primary	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		From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Primary	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		From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
Secondary	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		From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary	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		From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary	Percentage of infant participants reporting infant AESIs 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
Secondary	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		From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary	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		From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary	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		From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Secondary	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		From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Secondary	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		From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Secondary	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		From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination