NCT05966090

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age.

Conditions

• Respiratory Syncytial Viruses
• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA investigational vaccine	One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
BIOLOGICAL	HZ/su vaccine	Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-02-19
• Completion: 2024-07-29
• First posted: 2023-07-28
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

31 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study