CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 507 enrolled
Drug / intervention
RSV vaccine GSK3003895A (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/NCT02360475
NCT02360475Phase 2Completed
CompareCT.gov

An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

GlaxoSmithKline·interventional·Posted Feb 10, 2015·Updated Jul 3, 2018

In Brief

A Phase 2 clinical trial evaluating RSV vaccine GSK3003895A (formulation 1), RSV vaccine GSK3003898A (formulation 2), and 2 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 507 participants across 12 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesAustralia, Czechia, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 10, 2015
Enrollment StartMar 20, 2015
Primary CompletionJul 2, 2015
Study CompletionJun 21, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.4 years ago

Interventions

RSV vaccine GSK3003895A (formulation 1)biological

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

RSV vaccine GSK3003898A (formulation 2)biological

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

RSV vaccine GSK3003899A (formulation 3)biological

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

Boostrixbiological

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