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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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 21-35 days post vaccine

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met