Vaccine

Combined COVID-19 and Flu Shot for Coronavirus and Flu

Hialeah, FL

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

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

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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

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I am 50 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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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

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

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

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