NCT06534892

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,212 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA vaccine	RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-08-02
• Last updated: 2026-03-09

Locations

250 sites across 17 countries: United States, Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study