Status:
COMPLETED
Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Abt Associates
Clalit Research Institute
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with sta...
Detailed Description
This is a randomized, open-label study design. Starting in July 2019, approximately 550 to 700 HCP from two hospitals (275-350 per hospital site) in Israel will be enrolled. Following completion of a ...
Eligibility Criteria
Inclusion
- Aged ≥18
- Current member of Clalit Health Services
- Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or, if already vaccinated in the current year outside of the study, consent to receive a post-vaccination blood draw
- Participated in the SHIRI study and received influenza vaccination during the 2018-19 influenza season (Group 1)
- Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but vaccinated in at least one study year (Group 1 supplemental)
- Participated in the SHIRI study during all three years, regardless of vaccination status (Group 1 supplemental)
- Participated in any year of the SHIRI study and had PCR-confirmed influenza virus infection during any of the three study years (Group 2)
Exclusion
- Already received an influenza vaccine during the current influenza season
- Not willing or able to get the flu vaccines being used in this study;
- Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported by the subject
- Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in the 4 weeks following the first study visit
- Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study.
- Any condition or employment status that the potential participant or local study site principle investigator (PI) believes may interfere with successful completion of the study prior to December 2019, including being currently pregnant.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT04523324
Start Date
October 31 2019
End Date
August 30 2022
Last Update
November 15 2023
Active Locations (2)
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1
Soroka Medical Center
Beersheba, Israel
2
Rabin Medical Center-Beilinson
Petah Tikva, Israel