Trials / Completed
CompletedNCT05886777
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).
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,142 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Combination [RSVpreF+BNTb162b2] | Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection |
| BIOLOGICAL | Bivalent BNT162b2 (original/Omi BA.4/BA.5) | Bivalent BNT162b2 given as an intramuscular injection |
| BIOLOGICAL | RSVpreF | RSVpreF given as an intramuscular injection |
| BIOLOGICAL | QIV | Licensed QIV given as an intramuscular injection |
| BIOLOGICAL | Normal Saline Placebo | Normal saline (0.9% sodium chloride solution for injection) |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2023-06-02
- Last updated
- 2024-12-18
- Results posted
- 2024-12-18
Locations
37 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05886777. Inclusion in this directory is not an endorsement.