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A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women

NCT02956837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2019-07-02

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV Vaccine (GSK3003891A) formulation 1

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

BIOLOGICAL

RSV Vaccine (GSK3003891A) formulation 2

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

BIOLOGICAL

RSV Vaccine (GSK3003891A) formulation 3

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

DRUG

Placebo (Formulation buffer S9b)

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2017-08-30
Completion
2018-02-05

Countries

  • Belgium
  • Estonia
  • France
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956837 on ClinicalTrials.gov