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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.
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.
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 belowSelect...
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.
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My BMI is 35 or higher.
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I haven't had a flu shot or taken flu antiviral drugs in the last 6 months.
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I have had a stroke or a mini-stroke in the past.
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I have had Guillain-Barré syndrome in the past.
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I do not have HIV, hepatitis B, or hepatitis C.
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I have heart disease, high blood pressure, or a history of heart inflammation.
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I have or had an autoimmune disease that needed treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for up to 7 days following vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for up to 7 days following vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreTrial 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
4,625 Previous Clinical Trials
14,283,549 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,125 Total Patients Enrolled
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