Phase 3 Study to Test the Safety and Effectiveness of a Recombinant RSV Vaccine in Adults 60 Years and Older

What this Trial Is About

Researchers are evaluating the effectiveness of a Recombinant Respiratory Syncytial Virus RSV vaccine made from CHO cells in preventing lower respiratory tract diseases caused by RSV in adults aged 60 years and older. This Phase III trial aims to assess if a single dose of this vaccine is safe and stimulates an immune response. The study involves a large group of 25,000 participants divided into two age groups 60-69 years and 70 years or older. Participants will be randomly assigned to receive either the investigational RSV vaccine or a placebo injection, with each participant receiving a single intramuscular dose into the arm. The vaccine dose is 0.5 mL, and the placebo consists of saline solution. Researchers will monitor safety, immune response, and vaccine effectiveness over time, including a subgroup of 1,200 participants for detailed immune response testing. Throughout the study, participants will be followed for up to two RSV epidemic seasons, with evaluations starting 14 days after vaccination and continuing for up to 36 months. The research team will track the occurrence of respiratory illnesses, measure immune responses through blood tests at multiple time points, and monitor adverse events and safety. Participants will have scheduled visits to assess health, immune markers, and any side effects related to the vaccine or placebo.

Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)