Phase III study of BK1304 in healthy adults and adolescents

Phase 3

Completed

• Conditions: Prevention of influenza

• Registration Number: JPRN-jRCT2080224074
• Lead Sponsor: The Research Foundation for Microbial Diseases of Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-02
• Study Completion: 2019-08-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Influenza prevention effect(Vaccine Efficacy)

Secondary Outcome Measures

Name	Time	Method
safety<br>Adverse events and adverse reactions<br>other<br>Response rate, geometric mean titer and geometric mean titer increase of nasal IgA antibody<br>other<br>Geometric mean titer of nasal neutralizing antibody<br>other<br>Seroconversion rate, seroprotection rate, geometric mean titer and geometric mean titer increase of serum HI antibody