Trial Review

The ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Friday 6th June for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
25/03/2025

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
Completed
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
Actual
15/01/2025
Sample size
Target
Accrual to date
Final
3962
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
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Bangladesh
State/province [17] 0 0
Matlab
Country [18] 0 0
Bangladesh
State/province [18] 0 0
Sylhet
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Belgium
State/province [21] 0 0
Sint-Niklaas
Country [22] 0 0
Brazil
State/province [22] 0 0
Nova IguaCu
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
Country [24] 0 0
Brazil
State/province [24] 0 0
RibeirAo PretoSP
Country [25] 0 0
Brazil
State/province [25] 0 0
Santa Maria
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Jose Do Rio Preto
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
Colombia
State/province [31] 0 0
Barranquilla
Country [32] 0 0
Colombia
State/province [32] 0 0
Cali Colombia
Country [33] 0 0
Colombia
State/province [33] 0 0
Chia
Country [34] 0 0
Colombia
State/province [34] 0 0
Medellin
Country [35] 0 0
Dominican Republic
State/province [35] 0 0
Santo Domingo Este
Country [36] 0 0
Finland
State/province [36] 0 0
Espoo
Country [37] 0 0
Finland
State/province [37] 0 0
Helsinki
Country [38] 0 0
Finland
State/province [38] 0 0
Jarvenpaa
Country [39] 0 0
Finland
State/province [39] 0 0
Kokkola
Country [40] 0 0
Finland
State/province [40] 0 0
Oulu
Country [41] 0 0
Finland
State/province [41] 0 0
Pori
Country [42] 0 0
Finland
State/province [42] 0 0
Seinajoki
Country [43] 0 0
Finland
State/province [43] 0 0
Tampere
Country [44] 0 0
Finland
State/province [44] 0 0
Turku
Country [45] 0 0
France
State/province [45] 0 0
Bordeaux
Country [46] 0 0
France
State/province [46] 0 0
Bron
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
Germany
State/province [48] 0 0
Goch
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Hannover
Country [51] 0 0
Germany
State/province [51] 0 0
Mainz
Country [52] 0 0
Germany
State/province [52] 0 0
Wuerzburg
Country [53] 0 0
Honduras
State/province [53] 0 0
Comayagua
Country [54] 0 0
Honduras
State/province [54] 0 0
San Pedro Sula
Country [55] 0 0
India
State/province [55] 0 0
Kolkata
Country [56] 0 0
India
State/province [56] 0 0
Mangalore
Country [57] 0 0
India
State/province [57] 0 0
Mysore
Country [58] 0 0
India
State/province [58] 0 0
Nagpur
Country [59] 0 0
India
State/province [59] 0 0
Pune
Country [60] 0 0
India
State/province [60] 0 0
Vadu Budruk Pune
Country [61] 0 0
Italy
State/province [61] 0 0
Bari
Country [62] 0 0
Italy
State/province [62] 0 0
Messina
Country [63] 0 0
Italy
State/province [63] 0 0
Milano
Country [64] 0 0
Italy
State/province [64] 0 0
Prato
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Ansan
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
New Zealand
State/province [67] 0 0
Grafton Auckland
Country [68] 0 0
New Zealand
State/province [68] 0 0
Papatoetoe Auckland
Country [69] 0 0
New Zealand
State/province [69] 0 0
Wellington
Country [70] 0 0
Panama
State/province [70] 0 0
Ciudad de Panama
Country [71] 0 0
Panama
State/province [71] 0 0
Panama
Country [72] 0 0
Philippines
State/province [72] 0 0
Manila
Country [73] 0 0
South Africa
State/province [73] 0 0
Johannesburg
Country [74] 0 0
South Africa
State/province [74] 0 0
Pretoria
Country [75] 0 0
South Africa
State/province [75] 0 0
Soshanguve
Country [76] 0 0
South Africa
State/province [76] 0 0
Soweto Gauteng
Country [77] 0 0
Spain
State/province [77] 0 0
Aravaca
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
Country [79] 0 0
Spain
State/province [79] 0 0
Bilbao
Country [80] 0 0
Spain
State/province [80] 0 0
Boadilla Del Monte Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Burgos
Country [82] 0 0
Spain
State/province [82] 0 0
Getafe
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Malaga
Country [85] 0 0
Spain
State/province [85] 0 0
Marbella
Country [86] 0 0
Spain
State/province [86] 0 0
Santiago de Compostela
Country [87] 0 0
Spain
State/province [87] 0 0
Sevilla
Country [88] 0 0
Spain
State/province [88] 0 0
TorrejOn Ardoz Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Spain
State/province [90] 0 0
Valladolid
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taichung
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taoyuan
Country [94] 0 0
Thailand
State/province [94] 0 0
Bangkok
Country [95] 0 0
Thailand
State/province [95] 0 0
ChiangMai

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


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