Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
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.
Timeline
- Start
- 2020-07-02
- Primary completion
- 2021-09-20
- Completion
- 2021-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quadrivalent RIV with 2018-2019 NH H3 strain | Vaccine | — | Intramuscular |
| Comparator | Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant | Vaccine | — | Intramuscular |
| Subject | Quadrivalent RIV with H3 strain 1 | Vaccine | — | Intramuscular |
| Subject | Quadrivalent RIV with H3 strain 1 and adjuvant | Vaccine | — | Intramuscular |
| Subject | Quadrivalent RIV with H3 strain 2 | Vaccine | — | Intramuscular |
| Subject | Quadrivalent RIV with H3 strain 2 and adjuvant | Vaccine | — | Intramuscular |
Indications
No indication recorded.