NCT04451954

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study duration per participant is approximately 1 year

Conditions

• Influenza Immunisation
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent RIV with H3 strain 1	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent RIV with H3 strain 1 and adjuvant	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent RIV with H3 strain 2	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent RIV with H3 strain 2 and adjuvant	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent RIV with 2018-2019 NH H3 strain	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Timeline

• Start date: 2020-07-02
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2020-06-30
• Last updated: 2025-09-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study