CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 502 enrolled
Drug / intervention
GSK3888550A RSV Maternal vaccine 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/NCT03674177
NCT03674177Phase 1Completed
CompareCT.gov

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Unadjuvanted RSV Maternal Vaccine Compared to Placebo When Administered to Healthy Non-pregnant Women.

GlaxoSmithKline·interventional·Posted Sep 17, 2018·Updated Aug 13, 2021

In Brief

A Phase 1 clinical trial evaluating GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2, and 2 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 502 participants across 11 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 17, 2018
Enrollment StartOct 30, 2018
Primary CompletionApr 16, 2019
Study CompletionSep 2, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.8 years ago

Interventions

GSK3888550A RSV Maternal vaccine formulation 1biological

Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

GSK3888550A RSV Maternal vaccine formulation 2biological

Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

GSK3888550A RSV Maternal vaccine formulation 3biological

Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

Placebo (Normal Saline)drug

Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm