Status:
COMPLETED
Immunogenicity of Influenza Vaccinations
Lead Sponsor:
Duke University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Arizona State University
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an...
Eligibility Criteria
Inclusion
- Adults aged 18-64 years that have not received the current season's influenza vaccine
- English literate
- Email or text message capability for weekly follow-up
- Intention of receiving influenza vaccine based on ACIP-CDC guidelines
- Willing to provide written/electronic informed consent
- Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits
Exclusion
- Receipt of the current season's influenza vaccine (receipt after July 1, 2024)
- History of severe allergic reaction after a previous dose of any influenza vaccine or to an influenza vaccine component
- Receipt of any licensed or investigational live vaccine within 6 weeks or non-live vaccine within 2 weeks prior to enrollment in this study or planning receipt of any vaccines between visits 1 and 2 of the study (approximately within 4 weeks after the receipt of study-administered vaccine)
- History of Guillain-Barré syndrome
- Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives
- Temporary Delay Criteria (Visit 1)
- 1\. History of febrile illness (\> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2025
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT06518577
Start Date
September 9 2024
End Date
June 4 2025
Last Update
June 19 2025
Active Locations (7)
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1
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, United States, 85008
2
ASU Biodesign Institute
Tempe, Arizona, United States, 85281
3
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
4
Washington University IDCRU
St Louis, Missouri, United States, 63110