jRCT2080224074CompletedPhase 3
Phase III study of BK1304 in healthy adults and adolescents
The Research Foundation for Microbial Diseases of Osaka University1 site1,500 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Observer-blind
- Primary Purpose
- Prevention Purpose
Eligibility Criteria
- Ages
- 13age old over to 64age old under (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent is obtained from subject/legal guardian
Exclusion Criteria
- •Received BK1304 or intranasal administration of an inactivated influenza virus vaccine
- •History of influenza virus infection or influenza vaccination within 180 days prior to the first dose of study drug
- •History of anaphylaxis to food or drug
- •Judged ineligible for the study by investigator
Outcomes
Primary Outcomes
-
efficacy Influenza prevention effect(Vaccine Efficacy)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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