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Virus Vaccine

Comparing Flu Vaccines for Flu (PAIVED Trial)

Phase 4
Waitlist Available
Led By Timothy Burgess, MD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020, 2020-2021, 2021-2022) influenza vaccination
Must not have
Adults who have already received a flu vaccine within the current season
Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 21-35 days post vaccine
Awards & highlights

Summary

This trialwill study 18,000 people over 4 years, divided into 3 groups, to compare 3 flu vaccines.

Who is the study for?
This trial is for adults over 18 who can get texts or emails, are eligible for care at Department of Defense facilities, and haven't had a flu shot this season. It's not for those already vaccinated, with allergies to certain antibiotics, or intending to use FluMist Vaccine.
What is being tested?
The study compares three types of flu vaccines: cell-culture-based, recombinant, and egg-based. Over four years (2018-2022), 18,000 participants will be randomly assigned in equal numbers to receive one of these vaccines.
What are the potential side effects?
Common side effects from flu vaccines may include soreness at the injection site, headache, feverish feelings or muscle pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am getting my flu shot at a military site for one of the specified seasons.
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I am getting my flu shot at a military treatment site.
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I am 18 years old or older.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a flu vaccine this season.
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I cannot have a flu shot or standard doses because of another health issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 21-35 days post vaccine
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 21-35 days post vaccine for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Laboratory Confirmed Influenza
Secondary study objectives
Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Number of Participants With Influenza-Like Illness
+1 more
Other study objectives
Number of Participants With SARS-CoV-2 and Influenza Co-Infection
Symptom Severity of SARS CoV2

Trial Design

3Treatment groups
Active Control
Group I: Egg based influenza vaccinesActive Control1 Intervention
Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States.
Group II: Recombinant influenza vaccinesActive Control1 Intervention
FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States.
Group III: Cell-culture based influenza vaccinesActive Control1 Intervention
Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States.

Find a Location

Who is running the clinical trial?

Defense Health Agency Immunization Healthcare BranchUNKNOWN
Armed Forces Health Surveillance BranchUNKNOWN
Naval Health Research CenterFED
18 Previous Clinical Trials
159,877 Total Patients Enrolled

Media Library

Cell-culture based influenza vaccines (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03734237 — Phase 4
Flu Research Study Groups: Egg based influenza vaccines, Recombinant influenza vaccines, Cell-culture based influenza vaccines
Flu Clinical Trial 2023: Cell-culture based influenza vaccines Highlights & Side Effects. Trial Name: NCT03734237 — Phase 4
Cell-culture based influenza vaccines (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734237 — Phase 4
~2261 spots leftby Sep 2025
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