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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 21-35 days post vaccine
Awards & highlights
PAIVED Trial 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.Check my eligibility
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.See study design
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.
PAIVED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting my flu shot at a military site for one of the specified seasons.
Select...
I am getting my flu shot at a military treatment site.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
PAIVED Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Laboratory Confirmed Influenza
Secondary outcome measures
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 moreOther outcome measures
Number of Participants With SARS-CoV-2 and Influenza Co-Infection
Symptom Severity of SARS CoV2
PAIVED 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a flu vaccine this season.I am getting my flu shot at a military site for one of the specified seasons.I plan to get or have already received this season's FluMist vaccine.I am getting my flu shot at a military treatment site.You are allergic to gentamicin, polymyxin, or neomycin.I am 18 years old or older.I cannot have a flu shot or standard doses because of another health issue.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Egg based influenza vaccines
- Group 2: Recombinant influenza vaccines
- Group 3: Cell-culture based influenza vaccines
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Carl R. Darnall Army Medical Center
Why did patients apply to this trial?
Recent research and studies
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