Phase III study of BK1304 in healthy adults and adolescents

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224074

Enrollment

1500

Registered

2018-10-02

Start date

2018-10-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza

Interventions

investigational material(s) Generic name etc : BK1304 INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : 2 doses of i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent is obtained from subject/legal guardian

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy Influenza prevention effect(Vaccine Efficacy)	—

Secondary

Measure	Time frame
safety Adverse events and adverse reactions other Response rate, geometric mean titer and geometric mean titer increase of nasal IgA antibody other Geometric mean titer of nasal neutralizing antibody other Seroconversion rate, seroprotection rate, geometric mean titer and geometric mean titer increase of serum HI antibody	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026