Clinical trial
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Name
IDCRP-120
Description
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).
Trial arms
Trial start
2018-11-06
Estimated PCD
2022-07-07
Trial end
2024-05-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Egg based influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Arms:
Egg based influenza vaccines
Recombinant influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Arms:
Recombinant influenza vaccines
Cell-culture based influenza vaccines
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Arms:
Cell-culture based influenza vaccines
Size
15449
Primary endpoint
Number of Participants With Laboratory Confirmed Influenza
Onset > 13 days after vaccination up to 1 year
Eligibility criteria
Inclusion Criteria:
1. Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
2. ≥18 years of age.
3. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
4. Able to speak English and able to provide informed consent
5. Able to receive and respond to texts and/or emails, or a military recruit
Exclusion Criteria:
1. Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
2. Adults who have already received a flu vaccine within the current season
3. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
4. Allergic to gentamicin, polymyxin and/or neomycin
5. Individuals who fail to meet the inclusion criteria
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15449, 'type': 'ACTUAL'}}
Updated at
2023-11-24
1 organization
3 products
2 indications
Product
Egg based influenza vaccinesIndication
InfluenzaIndication
Influenza-like illness