Phase 2 study of BK1304 in healthy children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200156

Enrollment

120

Registered

2020-10-15

Start date

2020-10-01

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

injection of Investigational new drug

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A person who has written informed consent from legal guardian and has obtained an ascent from subject

Exclusion criteria

Exclusion criteria: 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
Response rate, geometric mean titer and geometric mean titer increase of nasal IgA antibody. Geometric mean titer of nasal neutralizing antibody. Seroconversion rate, seroprotection rate, geometric mean titer and geometric mean titer increase of serum HI antibody. Adverse events and adverse reactions.	—

Contacts

Public ContactHideyuki Fuji

The Research Foundation for Microbial Diseases of Osaka University

pivotal@mail.biken.or.jp

Outcome results

None listed

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