MedTrace Logo

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers

NCT03191383 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-10-15

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated 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)

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
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2017-07-14
Completion
2017-07-14
FDA Drug
Yes

Countries

  • United States
  • Finland
  • Spain

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 NCT03191383 on ClinicalTrials.gov