Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel

7250

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 standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

2019-10-31

2020-01-30

2022-08-30

Completed

Early phase I

577

Inclusion Criteria: * 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 Criteria: * 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.

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2023-11-15