← Back to Search

Vaccine

Combined COVID-19 and Flu Shot for Coronavirus and Flu

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
Male or female participants aged 50 years or older at Visit 1 (Day 1)
Be older than 18 years old
Must not have
Women who are pregnant, plan to become pregnant during the study, or are breastfeeding
Participants with a calculated BMI of ≥35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for up to 7 days following vaccination
Awards & highlights

Summary

This trial is testing whether it is safe and effective to combine the COVID-19 vaccine and the flu vaccine into one shot. The goal is to see if this combination can help the body produce antibodies to

Who is the study for?
This trial is for healthy adults aged 50 or older. It's designed to test if a combined shot for COVID-19 and the flu is safe and effective.Check my eligibility
What is being tested?
The study compares different shots: one with just the COVID-19 vaccine (BNT162b2), one with just the flu vaccine (RIV), a placebo, and a combination of both vaccines. Participants will be randomly assigned to receive one of these.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with vaccinations such as soreness at injection site, fever, fatigue, headache, muscle pain, chills or joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, planning to become pregnant, or breastfeeding.
Select...
My BMI is 35 or higher.
Select...
I haven't had a flu shot or taken flu antiviral drugs in the last 6 months.
Select...
I have had a stroke or a mini-stroke in the past.
Select...
I have had Guillain-Barré syndrome in the past.
Select...
I do not have HIV, hepatitis B, or hepatitis C.
Select...
I have heart disease, high blood pressure, or a history of heart inflammation.
Select...
I have or had an autoimmune disease that needed treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for up to 7 days following vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and for up to 7 days following vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, GMFR in HAI titers from before vaccination to 4 weeks after vaccination
In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, GMTs of hemagglutination inhibition (HAI) titers
In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 serum neutralizing titers
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: BNT162b2 (Omi XBB.1.5)/RIV and placeboExperimental Treatment2 Interventions
Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo
Group II: BNT162b2 (Omi XBB.1.5) and RIVExperimental Treatment2 Interventions
Participants will receive BNT162b2 (Omi XBB.1.5) and RIV
Group III: BNT162b2 (Omi XBB.1.5) and placeboActive Control2 Interventions
Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo
Group IV: RIV and placeboActive Control2 Interventions
Participants will receive RIV and normal saline placebo

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,868,175 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,044,784 Total Patients Enrolled
~85 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top