BARDA BP-I-23-001 H5 Influenza
NCT Number: NCT06560151
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Influenza
Sponsor: Biomedical Advanced Research and Development Authority
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1380
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-21
Completion Date: 2025-12

Summary:
This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.

Primary Outcome Measures: The percentage of participants who experience any solicited local reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day., Day 1 through Day 8 and Day 22 through Day 29|The percentage of participants who experience any solicited systemic reactogenicity symptom occurring within 8 days of each vaccination, inclusive of the vaccination day., Day 1 through Day 8 and Day 22 through Day 29|The percentage of participants achieving seroprotection at Day 43 based on serum HAI antibody titers (≥1:40) to A/Astrakhan (H5N8)., Day 43
Secondary Outcome Measures: The percentage of participants who experience any unsolicited TEAE within 22 days of each vaccination, inclusive of the vaccination day., Day 1 through Day 22 and Day 22 through Day 43|The percentage of participants who experience any treatment-emergent SAE., Day 1 through Day 203|The percentage of participants who experience any treatment-emergent MAAE., Day 1 through Day 203|The percentage of participants who experience any treatment-emergent pIMD., Day 1 through Day 203|The percentage of participants achieving seroprotection at Day 43 based on serum HAI antibody titers (≥1:40) to A/bar-headed goose (H5N1)., Day 43|Serum HAI antibody titers to A/Astrakhan (H5N8) at Screening., Screening|Serum HAI antibody titers to A/Astrakhan (H5N8) at Day 22., Day 22|Serum HAI antibody titers to A/Astrakhan (H5N8) at Day 43., Day 43|Serum HAI antibody titers to A/Astrakhan (H5N8) at Day 203., Day 203|Serum HAI antibody titers to A/bar-headed goose (H5N1) at Screening., Screening|Serum HAI antibody titers to A/bar-headed goose (H5N1) at Day 22., Day 22|Serum HAI antibody titers to A/bar-headed goose (H5N1) at Day 43., Day 43|Serum HAI antibody titers to A/bar-headed goose (H5N1) at Day 203, Day 203|The percentage of participants achieving seroprotection at Day 22 based on serum HAI antibody titers (≥1:40) to A/Astrakhan (H5N8)., Day 22|The percentage of participants achieving seroprotection at Day 203 based on serum HAI antibody titers (≥1:40) to A/Astrakhan (H5N8)., Day 203|The percentage of participants achieving seroprotection at Day 22 based on serum HAI antibody titers (≥1:40) to A/bar-headed goose (H5N1)., Day 22|The percentage of participants achieving seroprotection at Day 203 based on serum HAI antibody titers (≥1:40) to A/bar-headed goose (H5N1)., Day 203|The percentage of participants achieving seroconversion at Day 22 based on serum HAI antibody titers to A/Astrakhan (H5N8)., Day 22|The percentage of participants achieving seroconversion at Day 43 based on serum HAI antibody titers to A/Astrakhan (H5N8)., Day 43|The percentage of participants achieving seroconversion at Day 203 based on serum HAI antibody titers to A/Astrakhan (H5N8)., Day 203|The percentage of participants achieving seroconversion at Day 22 based on serum HAI antibody titers to A/bar-headed goose (H5N1)., Day 22|The percentage of participants achieving seroconversion at Day 43 based on serum HAI antibody titers to A/bar-headed goose (H5N1)., Day 43|The percentage of participants achieving seroconversion at Day 203 based on serum HAI antibody titers to A/bar-headed goose (H5N1)., Day 203|Serum MN antibody titers to A/Astrakhan (H5N8) at Screening., Screening|Serum MN antibody titers to A/Astrakhan (H5N8) at Day 22., Day 22|Serum MN antibody titers to A/Astrakhan (H5N8) at Day 43., Day 43|Serum MN antibody titers to A/Astrakhan (H5N8) at Day 203., Day 203|Serum MN antibody titers to A/bar-headed goose (H5N1) at Screening., Screening|Serum MN antibody titers to A/bar-headed goose (H5N1) at Day 22., Day 22|Serum MN antibody titers to A/bar-headed goose (H5N1) at Day 43., Day 43|Serum MN antibody titers to A/bar-headed goose (H5N1) at Day 203., Day 203|The percentage of participants achieving seroconversion at Day 22 based on serum MN antibody titers to A/Astrakhan (H5N8)., Day 22|The percentage of participants achieving seroconversion at Day 43 based on serum MN antibody titers to A/Astrakhan (H5N8)., Day 43|The percentage of participants achieving seroconversion at Day 203 based on serum MN antibody titers to A/Astrakhan (H5N8)., Day 203|The percentage of participants achieving seroconversion at Day 22 based on serum MN antibody titers to A/bar-headed goose (H5N1)., Day 22|The percentage of participants achieving seroconversion at Day 43 based on serum MN antibody titers to A/bar-headed goose (H5N1)., Day 43|The percentage of participants achieving seroconversion at Day 203 based on serum MN antibody titers to A/bar-headed goose (H5N1)., Day 203