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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05705440




Registration number
NCT05705440
Ethics application status
Date submitted
20/01/2023
Date registered
30/01/2023

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
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
Secondary ID [1] 0 0
2022-003124-41
Secondary ID [2] 0 0
219510
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: 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).
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary outcome [3] 0 0
Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Timepoint [3] 0 0
From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Secondary outcome [4] 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 any pregnancy conceived within 2 years post-vaccination
Timepoint [4] 0 0
From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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
Timepoint [6] 0 0
From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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
Timepoint [7] 0 0
From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Secondary outcome [9] 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 the first pregnancy conceived within 2 years post-vaccination
Timepoint [9] 0 0
From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination

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.
Minimum age
9 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/02/2025
Actual
Sample size
Target
4129
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Southport
Recruitment hospital [3] 0 0
GSK Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Rio Cuarto
Country [19] 0 0
Bangladesh
State/province [19] 0 0
Dhaka
Country [20] 0 0
Bangladesh
State/province [20] 0 0
Sylhet
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Sint-Niklaas
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
São Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Alto Da Posse, Nova Iguacu
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Québec
Country [32] 0 0
Colombia
State/province [32] 0 0
Barranquilla
Country [33] 0 0
Colombia
State/province [33] 0 0
Cali
Country [34] 0 0
Colombia
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Chía
Country [35] 0 0
Colombia
State/province [35] 0 0
Medellin
Country [36] 0 0
Dominican Republic
State/province [36] 0 0
Santo Domingo
Country [37] 0 0
Finland
State/province [37] 0 0
Espoo
Country [38] 0 0
Finland
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Helsinki
Country [39] 0 0
Finland
State/province [39] 0 0
Jarvenpaa
Country [40] 0 0
Finland
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Kokkola
Country [41] 0 0
Finland
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Oulu
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Finland
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Pori
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Finland
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Seinajoki
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Finland
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Tampere
Country [45] 0 0
Finland
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Turku
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France
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Bordeaux
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France
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Bron
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France
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Paris
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Hamburg
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Honduras
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Comayagua
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Honduras
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San Pedro Sula
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India
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Maharashtra
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India
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Kolkata
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India
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Mangalore
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India
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Mysuru
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India
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Nagpur
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India
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Pune
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Verona
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Korea, Republic of
State/province [67] 0 0
Ansan
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Korea, Republic of
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Seoul
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Mexico
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Nuevo León
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Mexico
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Querétaro
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Mexico
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Oaxaca
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New Zealand
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Auckland
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New Zealand
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Newtown, Wellington
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Panama
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Ciudad de Panama
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Panama
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La Chorrera
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Panama
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Panama
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Philippines
State/province [77] 0 0
Manila
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South Africa
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Gauteng
Country [79] 0 0
South Africa
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Soshanguve
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Spain
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Andalucia
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Spain
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Madrid
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Spain
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Aravaca
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Spain
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Barcelona
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Spain
State/province [84] 0 0
Bilbao
Country [85] 0 0
Spain
State/province [85] 0 0
Burgos
Country [86] 0 0
Spain
State/province [86] 0 0
Gandía (Valencia)
Country [87] 0 0
Spain
State/province [87] 0 0
Getafe/Madrid
Country [88] 0 0
Spain
State/province [88] 0 0
Majadahonda (Madrid)
Country [89] 0 0
Spain
State/province [89] 0 0
Malaga
Country [90] 0 0
Spain
State/province [90] 0 0
Marbella
Country [91] 0 0
Spain
State/province [91] 0 0
Santiago de Compostela
Country [92] 0 0
Spain
State/province [92] 0 0
Sevilla
Country [93] 0 0
Spain
State/province [93] 0 0
Torrejón Ardoz
Country [94] 0 0
Spain
State/province [94] 0 0
Valencia
Country [95] 0 0
Spain
State/province [95] 0 0
Valladolid
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taichung
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan
Country [99] 0 0
Thailand
State/province [99] 0 0
Bangkok
Country [100] 0 0
Thailand
State/province [100] 0 0
Muang

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05705440