CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 406 enrolled
Drug / intervention
RSV Vaccine (GSK3003891A) formulation 1 +3 morebiological
Likely dose
Not stated in 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/NCT02956837
NCT02956837Phase 2Completed
CompareCT.gov

An Observer-blind Study to Rank Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A) Administered to Healthy Women

GlaxoSmithKline·interventional·Posted Nov 7, 2016·Updated Jul 2, 2019

In Brief

A Phase 2 clinical trial evaluating RSV Vaccine (GSK3003891A) formulation 1, RSV Vaccine (GSK3003891A) formulation 2, and 2 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 406 participants across 8 sites in 4 countries.

Detailed Summary

The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesBelgium, Estonia, France, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 7, 2016
Enrollment StartNov 10, 2016
Primary CompletionAug 30, 2017
Study CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.7 years ago

Interventions

RSV Vaccine (GSK3003891A) formulation 1biological

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

RSV Vaccine (GSK3003891A) formulation 2biological

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

RSV Vaccine (GSK3003891A) formulation 3biological

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

Placebo (Formulation buffer S9b)drug

A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.