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

Study duration per participant is approximately 1 year

Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects

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.

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

Recruitment

Summary

Participation Requirements

Description

Tracking Information