Phase 2 study of BK1304 in healthy children

JRCT ID: jRCT2031200156

Registered date:15/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of influenza
• Date of first enrollment: 01/10/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): injection of Investigational new drug

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 13age old
• Gender: Both
• Include criteria: A person who has written informed consent from legal guardian and has obtained an ascent from subject

Exclude 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

Related Information

• Primary Sponsor: Fuji Hideyuki