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Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women

NCT02753413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-06-26

Study results available
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Summary

The purpose of this study is to assess the safety and reactogenicity 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 GSK3003891A

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
2016-04-01
Primary Completion
2016-06-28
Completion
2016-06-28

Countries

  • Belgium

Study Locations

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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 NCT02753413 on ClinicalTrials.gov