Comparing Flu Vaccines for Flu
(PAIVED Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byTimothy Burgess, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).

Eligibility Criteria

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.

Inclusion Criteria

Able to receive and respond to texts and/or emails, or a military recruit

I am getting my flu shot at a military site for one of the specified seasons.

I am getting my flu shot at a military treatment site.

+4 more

Exclusion Criteria

I have received a flu vaccine this season.

I plan to get or have already received this season's FluMist vaccine.

You are allergic to gentamicin, polymyxin, or neomycin.

+2 more

Participant Groups

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.

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.