NCT04138056

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

A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-02-25
• Completion: 2021-11-22
• First posted: 2019-10-24
• Last updated: 2024-08-21
• Results posted: 2022-12-19

Locations

8 sites across 3 countries: United States, Belgium, Canada

Regulatory

• FDA-regulated drug study