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Vaccine

BNT162b2 (Omi XBB.1.5) and RIV for Flu

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for up to 7 days following vaccination
Awards & highlights

Study 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.

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
4,545 Previous Clinical Trials
11,422,188 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,457 Previous Clinical Trials
8,603,658 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the aforementioned medical research being conducted in a substantial number of healthcare facilities across the United States?

"Several medical research facilities, including Diablo Clinical Research, Inc. in Walnut Creek, Orange County Research Center in Tustin, and GW Medical Faculty Associates in Washington D.C., are currently enrolling patients for this trial. In addition to these three locations, there are 17 other sites where patients can participate as well."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"According to the latest information available on clinicaltrials.gov, this particular study is not currently enrolling participants. Although it was initially posted on January 31st, 2024 and last updated on January 30th, 2024, patient recruitment is not ongoing at present. However, there are a substantial number of other trials—specifically, 645—that are actively seeking patients for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
Orange County Research Center
Optimal Research
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Protection due to my age. Past trials have been without complications for me. It is important for medical research so there is acceptance in the general population.
PatientReceived no prior treatments
~427 spots leftby Sep 2024