Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age

Summary

The primary objectives of the study are: * To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. * To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study 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 HAI and SN antibody responses in each group against each of the H3 antigens. * To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.

Timeline

Start

2019-11-06

Primary completion

2020-02-24

Completion

2020-02-24

Drugs

Indications