At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATE(S) AGAINST INFECTIOUS RESPIRATORY ILLNESSES, INCLUDING COVID-19 AND RSV, IN HEALTHY INDIVIDUALS
In Brief
A Phase 2 clinical trial evaluating Combination [RSVpreF+BNTb162b2], Bivalent BNT162b2 (original/Omi BA.4/BA.5), and 3 other interventions for Healthy Participants. Completed, enrolled 1,142 participants across 37 sites.
Detailed 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.
Study Details
Timeline
Interventions
Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Bivalent BNT162b2 given as an intramuscular injection
RSVpreF given as an intramuscular injection
Licensed QIV given as an intramuscular injection
Normal saline (0.9% sodium chloride solution for injection)