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A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women

NCT03674177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2021-08-13

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

GSK3888550A RSV Maternal vaccine formulation 1

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

BIOLOGICAL

GSK3888550A RSV Maternal vaccine formulation 2

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

BIOLOGICAL

GSK3888550A RSV Maternal vaccine formulation 3

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

DRUG

Placebo (Normal Saline)

Single dose administered intramuscularly at Day 1 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
2018-10-30
Primary Completion
2019-04-16
Completion
2019-09-02
FDA Drug
Yes

Countries

  • United States
  • Finland
  • 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 NCT03674177 on ClinicalTrials.gov