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A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

NCT04138056 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2024-08-21

Study results available
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Summary

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF3 formulation 3

One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.

BIOLOGICAL

RSVPreF3 formulation 2

One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.

BIOLOGICAL

Boostrix-ex-US

One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.

BIOLOGICAL

Boostrix-US

One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.

DRUG

Placebo

One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-02-25
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada

Study Locations

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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 NCT04138056 on ClinicalTrials.gov