臨床研究等提出・公開システム

Date of registration	Oct. 15, 2020
Last modified on	Jan. 20, 2021
Trial ID	jRCT2031200156

Scientific Title	Phase 2 study of BK1304 in healthy children
Public Title	Phase 2 study of BK1304 in healthy children


Contact for Scientific Queries	Name	Fuji Hideyuki
	Affiliation	The Research Foundation for Microbial Diseases of Osaka University
	Address	3-1, Yamada-oka, Suita, Osaka
	E-mail	pivotal@mail.biken.or.jp
Contact for Public Queries	Name	Fuji Hideyuki
	Affiliation	The Research Foundation for Microbial Diseases of Osaka University
	Address	3-1, Yamada-oka, Suita, Osaka

	E-mail	pivotal@mail.biken.or.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 01, 2020
Actual date of first enrollment		Oct. 01, 2020
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	A person who has written informed consent from legal guardian and has obtained an ascent from subject
	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
	Age Minimum	6age old over
	Age Maximum	13age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of influenza
Intervention(s)		injection of Investigational new drug
Primary Outcome(s)		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.

Primary Sponsor	The Research Foundation for Microbial Diseases of Osaka University

Name of Certified Review Board	Sugiura Clinic Institutional Review Board
Address	4-4-16-301, Hon-cho, Kawaguchi-City, Saitama
Approval Status	Approval
Date of approval	Sept. 03, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 20, 2021	(this page)	Changes
1	Oct. 15, 2020	Detail

List of change history