Pfizer launches Phase 3 trial of RSV vaccine for older adults

Sept. 3, 2021

Pfizer has launched a Phase 3 clinical trial evaluating a single dose of its respiratory syncytial virus (RSV) vaccine in adults 60 years old or older.

Called RENOIR (RSV) vaccine Efficacy study iNOlder adults Immunized against RSV disease), the study will evaluate the company’s RSV bivalent prefusion F subunit investigational vaccine candidate (RSVpreF).

“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly contagious disease,” said Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research and Development at Pfizer.

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study. Pfizer expects to enroll approximately 30,000 participants 60 years old and older. The study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.

Respiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness. The virus is highly contagious and affects the lungs and airways. Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be potentially life-threatening.

In July 2021, Pfizer provided an update on a Phase 2a study evaluating the safety, immunogenicity and efficacy of RSVpreF in a virus challenge model in healthy adults 18 to 50 years of age. The results of the study enabled Pfizer to proceed to Phase 3.

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