Your session is about to expire
← Back to Search
Virus Therapy
Combined Vaccine for COVID-19 Prevention
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after vaccination (day 28)
Awards & highlights
Study Summary
This trial is studying the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone in people 65+.
Who is the study for?
This trial is for people aged 65 or older who are healthy or have stable chronic conditions. They must have had at least three US-authorized mRNA COVID-19 vaccines, with the last being a bivalent booster given over 150 days ago. Participants should not have received a flu shot in the past 120 days and must be able to attend all study visits and procedures.Check my eligibility
What is being tested?
The trial is testing a combined vaccine against RSV and COVID-19, which may also be administered with a seasonal flu vaccine. The goal is to see if this combination can safely reduce the number of shots needed to prevent respiratory infections.See study design
What are the potential side effects?
While specific side effects aren't listed, typical reactions could include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. Severe allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after vaccination (day 28)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after vaccination (day 28)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Group 1 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
Group 1 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
+8 moreSecondary outcome measures
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 Omicron BA.4/BA.5-strain neutralizing titers (NTs)
Group 6 vs Group 3 noninferiority analysis: Geometric mean ratios (GMRs) of SARS-CoV-2 reference-strain neutralizing titers (NTs)
Group 6 vs Group 4 noninferiority analysis: Geometric mean ratios (GMRs) of RSV A and RSV B neutralizing titers (NTs)
+4 moreTrial Design
7Treatment groups
Experimental Treatment
Active Control
Group I: Group 7Experimental Treatment3 Interventions
Coadministration RSVpreF + bivalent BNT162b2 + QIV
Group II: Group 6Experimental Treatment3 Interventions
Coadministration RSVpreF + bivalent BNT162b2 + placebo
Group III: Group 2Experimental Treatment2 Interventions
Combination [RSVpreF+BNT162b2] + placebo
Group IV: Group 1Experimental Treatment2 Interventions
Combination [RSVpreF+BNT162b2] + Quadrivalent influenza vaccine (QIV)
Group V: Group 4Active Control2 Interventions
RSVpreF + placebo
Group VI: Group 5Active Control2 Interventions
QIV + placebo
Group VII: Group 3Active Control2 Interventions
BNT162b2 + placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bivalent BNT162b2 (original/Omi BA.4/BA.5)
2023
Completed Phase 2
~1090
RSVpreF
2023
Completed Phase 3
~17130
Combination [RSVpreF+BNTb162b2]
2023
Completed Phase 2
~1090
Normal Saline Placebo
2023
Completed Phase 4
~1740
QIV
2022
Completed Phase 3
~5540
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,568 Previous Clinical Trials
10,910,802 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,970 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Participants must be 65 years old or older at the first visit.You have a condition that makes it unsafe for you to receive an injection in your muscle because it could cause prolonged bleeding.You are allergic to eggs or chicken.You have a weakened immune system due to a medical condition or medication.You have received a respiratory syncytial virus (RSV) vaccine before or plan to get one during the study.You are 65 years old or older at the first visit.You have received at least 3 mRNA COVID-19 vaccines, with the most recent being an updated vaccine given at least 150 days before the start of the study.You have been diagnosed with COVID-19, RSV infection, or the flu in the last 120 days.You had a bad reaction to a vaccine or are very allergic to any part of the study treatment.You got a flu shot within the last 120 days before the study starts.You have received at least three mRNA COVID-19 vaccines, with the most recent one being an updated version given at least 150 days before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4
- Group 2: Group 5
- Group 3: Group 7
- Group 4: Group 1
- Group 5: Group 2
- Group 6: Group 3
- Group 7: Group 6
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05886777 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key goals is this clinical research endeavor striving to achieve?
"According to information provided by Pfizer, the primary outcome being assessed over a one-month period post vaccination (Day 28) will be a noninferiority analysis between Groups 1 and 5: Hemagglutination Inhibtion titers Geometric Mean Ratios. The trial is also examining secondary outcomes such as Noninferiority analyses of RSV A/B Neutralizing Titers GMRs between Group 7 and 4, SARS-CoV2 Omicron BA.4/BA.5 Strain NTs GMRs between Group 7 and 3, and Influenza HAI titres GMRs between Group"
Answered by AI
Is the current research project open to new participants?
"According to the information on clinicaltrials.gov, this medical experiment is actively searching for participants. The trial was established on June 5th 2023 and its details were further updated on June 21st of that same year."
Answered by AI
How many participants are being observed in this research initiative?
"This trial requires 1050 eligible participants, and those interested can sign up at Marvel Clinical Research in Huntington Beach or Artemis Institute for Clinical Research in San Diego."
Answered by AI
At how many sites has this trial been implemented?
"The current list of sites enrolled in this trial is composed of 32 different facilities, with prominent locations including Huntington Beach, San Diego and Tustin. To reduce the burden on participants, it is advised to select a nearby site for participation."
Answered by AI
Has Group 6 achieved regulatory approval from the Food and Drug Administration?
"Our experts at Power have predetermined that Group 6 has moderate safety, rating it a 2 on the 1-3 scale. This is because this phase two trial lacks evidence of efficacy but supports its own security."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
California
Pennsylvania
What site did they apply to?
Artemis Institute for Clinical Research
Diablo Clinical Research, Inc.
Suncoast Research Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Interested in keeping healthy. I just completed a 6 year Eli Lilly study for a possible drug to slow Alzheimer's. Unfortunately, the drug didn't perform as desired.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger