drugset / Trial / 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

NCT06534892

Phase 3 Active not recruiting 10212 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2024-08-01
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject RSVPreF3 OA vaccine Vaccine