A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

Summary

The purpose of the study is to learn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections. This study is seeking participants who: * are 65 years of age or older. * are healthy or have well-controlled chronic conditions. * in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1). * have not had a flu shot in the last 120 days. * agree to be present for all study visits, procedures, and blood draws. Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.

Timeline

Start

2023-06-05

Primary completion

2024-01-01

Completion

2024-01-01

Publications

• Neutel JM, Erdem R, Jiang Q, Cannon K, Stacey H, Newton R, Gomme E, Li W, Mensa FJ, Tureci O, Sahin U, Swanson KA, Munjal I, Cooper D, Koury K, Anderson AS, Gurtman A, Kitchin N; C5481001 Study Group. Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults >/= 65 Years of Age. Vaccines (Basel). 2025 Feb 5;13(2):158. doi: 10.3390/vaccines13020158.

Drugs

Indications

No indication recorded.