CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 534 enrolled
Drug / intervention
RSV MAT 60 µg +2 morebiological
Likely dose
RSV MAT 60 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04126213
NCT04126213Phase 2Completed
CompareCT.gov

A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

GlaxoSmithKline·interventional·Posted Oct 15, 2019·Updated Dec 13, 2021

In Brief

A Phase 2 clinical trial evaluating RSV MAT 60 µg, RSV MAT 120 µg, and 1 other intervention for Respiratory Syncytial Virus Infections. Completed, enrolled 534 participants across 32 sites in 9 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesAustralia, Canada, Finland, France, New Zealand, Panama, South Africa, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 15, 2019
Enrollment StartNov 5, 2019
Primary CompletionJul 23, 2020
Study CompletionMay 14, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.7 years ago

Interventions

RSV MAT 60 µgbiological

One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

RSV MAT 120 µgbiological

One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Placebodrug

One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.