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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
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