Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560151
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
BARDA BP-I-23-001 H5 Influenza
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-Blind Phase 2 Study to Assess Safety and Immunogenicity of AH5 Inactivated Monovalent Influenza Vaccines At Different Antigen Dose Levels Adjuvanted with AS03 or MF59
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This BARDA-sponsored randomized double-blind phase 2 study is designed to assess safety and immunogenicity of AH5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59
Detailed Description:
This is a randomized double-blind phase 2 study to assess safety and immunogenicity of egg-based H5N8 and H5N1 influenza vaccines at different antigen dose levels 375 75 and 15 μg adjuvanted with AS03A full dose AS03A half dose H5N8 only or MF59 AS03A is the adjuvant AS03 Healthy adult male and female non-pregnant participants aged 18 years and older will be screened for baseline health status to ensure trial eligibility Participants meeting all the inclusion and none of the exclusion criteria will be randomized to receive vaccine doses according to treatment groups defined by antigen H5N1 or H5N8 antigen dose level 375 75 and 15 μg and adjuvant AS03A full dose AS03A half dose or MF59 Two doses of adjuvanted vaccine separated by 21 days will be administered to approximately 1380 participants including 780 participants 18 through 64 years old who will be randomized equally to 1 of 13 treatment groups A B C D E F G H I J K M and N and 600 participants 65 years old who will be randomized equally to 1 of 10 treatment groups B C E F H I K L N and O
Safety assessments will be based on solicited AEs local and systemic reactogenicity symptoms with onset within 8 days following each vaccination inclusive of the vaccination day Day 1 through Day 8 and Day 22 through Day 29 unsolicited TEAEs with onset within 22 days following each vaccination inclusive of the vaccination day Day 1 through Day 22 and Day 22 through Day 43 and treatment-emergent SAEs pIMDs and MAAEs occurring during study participation through Day 203 Immunogenicity assessments will include titer seroprotection rate and seroconversion rate based on serum HAI antibodies and titer and seroconversion rate based on serum MN antibodies Study vaccines will be prepared and administered by unblinded personnel All other trial assessments will be performed only by blinded personnel
Safety assessments will be based on solicited AEs local and systemic reactogenicity symptoms with onset within 8 days following each vaccination inclusive of the vaccination day Day 1 through Day 8 and Day 22 through Day 29 unsolicited TEAEs with onset within 22 days following each vaccination inclusive of the vaccination day Day 1 through Day 22 and Day 22 through Day 43 and treatment-emergent SAEs pIMDs and MAAEs occurring during study participation through Day 203 Immunogenicity assessments will include titer seroprotection rate and seroconversion rate based on serum HAI antibodies and titer and seroconversion rate based on serum MN antibodies Study vaccines will be prepared and administered by unblinded personnel All other trial assessments will be performed only by blinded personnel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None