Pfizer To Start Phase 3 Clinical Trial in Adults for Investigational Respiratory Synctial Virus Vaccine

Pfizer has launched the RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease (RENOIR) phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate in adults 60 years of age and older, according to a press release.

RSV is defined as a seasonal illness that starts in the fall months and peaks during the winter when other respiratory illnesses are more common.

“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 & Development at Pfizer Inc, in the press release. “The start of this phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.”

The RENOIR trial is set to enroll approximately 30,000 participants 60 years of age and older, with a main objective to assess the safety and efficacy for the prevention of moderate to severe lower respiratory tract illness during the first RSV season, according to the press release.

REFERENCE

Pfizer announces start of phase 3 clinical trial in adults for its investigational vaccine against respiratory syncytial virus (RSV). Pfizer. September 2, 2021. Accessed September 7, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-start-phase-3-clinical-trial-adults-its