Results

On February 16, 2023, The New England Journal of Medicine published the results of this study.

Conclusion

After 24,966 participants received the vaccine or placebo, the data concluded that a single dose of the RSVPreF3 OA vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-related lower respiratory tract disease in adults 60 years of age or older, regardless of RSV subtype and the presence of underlying coexisting conditions.

Phase 3 Study

This Phase 3 study evaluated the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH).

This phase 3 study will also assess if the vaccine is safe and induces an immune response.