Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101800162440 Date of Registration: 19/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A phase 3, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy
Official scientific title A phase 3, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy
Brief summary describing the background and objectives of the trial A trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Matisse
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Prevention of respiratory tract illness caused by a virus called Respiratory Syncytial Virus
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 16/06/2020
Actual trial start date 17/06/2020
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 6900
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://clinicaltrials.gov/ct2/show/NCT04424316?term=c3671008&draw=2&rank=1
Secondary Ids Issuing authority/Trial register
C3671008 Sponsor-issued trial/protocolnumber
NCT04424316 ClinicalTrials.gov Identifier
017931 U.S. Food and Drug Administration
201900294385 European Clinical Trials Database
DOH 27 072020 8801 South African Clinical Trials Register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RSVpreF 120 µg. Single dose at the vaccination visit The active ingredients in RSVpreF are 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B, in a lyophilized dosage form for reconstitution. 3450
Control Group placebo N/A Singe dose at the vaccination visit Lyophile match to RSVpreF. 3450 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Please refer to clintrials.gov or protocol for complete Inclusion/Exclusion criteria. In brief, healthy women >=18 and <=49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination with an uncomplicated, singleton pregnancy who are at no increased risk for complications. Please refer to clintrials.gov or protocol for complete Inclusion/Exclusion criteria. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2020 Gambia Government MRCG Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 273 Banju Fajara - Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Refer to the protocol section 3.1 Refer to the protocol section 3.1
Secondary Outcome Refer to the protocol section 3.1 Refer to the protocol section 3.1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Unit The Gambia at LSHTM Atlantic Boulevard Fajara KMC Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Pfizer Inc. 235 East 42nd street New York NY 10017 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pfizer Inc. 235 East 42nd Street New York NY 10017 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Beate Kampmann Beate.Kampmann@lshtm.ac.uk +447833170145 Atlantic Boulevard
City Postal code Country Position/Affiliation
Fajara KMC Gambia Theme Leader Vaccines and Immunity
Role Name Email Phone Street address
Public Enquiries Pfizer CT.gov Call Center ClinicalTrials.gov_Inquiries@pfizer.com +18007181021 NA
City Postal code Country Position/Affiliation
NA United States of America Pfizer CT.gov Call Center
Role Name Email Phone Street address
Scientific Enquiries Pfizer CT.gov Call Center ClinicalTrials.gov_Inquiries@pfizer.com +18007181021 NA
City Postal code Country Position/Affiliation
NA United States of America Pfizer CT.gov Call Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical-trials/trial-data-and-results/data-requests Clinical Study Report 6 months after LSLV or 02-2024. Data from Pfizer-sponsored global interventional clinical studies are available from: Trials conducted for medicines, vaccines and medical devices for indications that have been approved in the US and/or EU. Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. development for all indications has been discontinued). Pfizer will consider requests from qualified researchers for access to Pfizer clinical data. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Qualified researchers proposals are submitted via the Vivli platform.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.pfizer.com/science/clinical-trials/trial-data-and-results/data-requests No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information