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Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

NCT02360475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2018-07-03

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV vaccine GSK3003895A (formulation 1)

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

BIOLOGICAL

RSV vaccine GSK3003898A (formulation 2)

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

BIOLOGICAL

RSV vaccine GSK3003899A (formulation 3)

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

BIOLOGICAL

Boostrix

Single dose 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
2015-03-20
Primary Completion
2015-07-02
Completion
2016-06-21

Countries

  • United States
  • Australia
  • Czechia
  • 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 NCT02360475 on ClinicalTrials.gov