Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects

  • STATUS
    Recruiting
  • participants needed
    210
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 22 February 2022
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strain
immunomodulators
influenza

Summary

The primary objectives of the study are:

  • To describe the safety profile of the different formulations in all participants
  • To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives are:

  • To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
  • To describe SN antibody responses in each group against each of the H3 antigens.
  • To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.
  • To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

Description

Study duration per participant is approximately 1 year

Details
Condition Influenza Vaccine, Influenza, Influenza
Age 18years - 100years
Treatment Quadrivalent RIV with H3 strain 1, Quadrivalent RIV with H3 strain 1 and adjuvant, Quadrivalent RIV with H3 strain 2, Quadrivalent RIV with H3 strain 2 and adjuvant, Quadrivalent RIV with 2018-2019 NH H3 strain, Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Clinical Study IdentifierNCT04451954
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on22 February 2022

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