Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507553
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Study of Influenza Vaccines Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Translational Phase I Randomized Parallel-group Multi-arm Study to Evaluate Safety and Immunogenicity of an Influenza Vaccine Formulation Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Study FBP00005 is planned to be a translational Phase I randomized modified double-blind active-controlled multi-center study to be conducted in 2 stages in approximately 400 adults 18 to 49 years of age and 60 years of age in Australia The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain compared to formulations containing a single strain from each influenza virus subtype
Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose Adults 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose
Enrollment of participants in Stage 2 will occur after review of and be guided by safety and immunogenicity results from Stage 1 The study duration will be approximately 3 weeks
Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose Adults 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose
Enrollment of participants in Stage 2 will occur after review of and be guided by safety and immunogenicity results from Stage 1 The study duration will be approximately 3 weeks
Detailed Description:
None
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