臨床研究等提出・公開システム

Date of registration	Oct. 02, 2018
Last modified on	Jan. 20, 2020
Trial ID	jRCT2080224074

Scientific Title	Phase III study of BK1304 in healthy adults and adolescents
Public Title	Phase III study of BK1304 in healthy adults and adolescents

Completion Date or Terminated date	Aug. 05, 2019
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Undecided
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Biken
	Address
	Phone Number	+81-6-6877-4812
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Biken
	Address
	Phone Number	+81-6-6877-4812
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Oct. 13, 2018
Target Sample Size		1500
Study Type		Interventional
Study Design	Study Design	observer-blind
Study Design	Objective	prevention purpose
Phase		3
Key inclusion & exclusion criteria	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
	Minimum Age	13age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Prevention of influenza
Intervention(s)		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 intranasal administration control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : 2 doses of intranasal administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Influenza prevention effect(Vaccine Efficacy)
Secondary Outcome		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

Primary Sponsor	The Research Foundation for Microbial Diseases of Osaka University
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board of heishinkai Medical Group Incorporated OPHAC Hospital
Address of IRB	4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka, 532-0003, JAPAN
Phone Number of IRB	+81-6-6395-9000
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Sept. 20, 2018

Name of IRB	Institutional Review Board of Medical Corporation Shinanokai, Shinanozaka Clinic
Address of IRB	Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo, 160-0017, JAPAN
Phone Number of IRB	+81-3-5366-3006
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Sept. 20, 2018

Secondary ID No.	JapicCTI-184135
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Jan. 20, 2020	(this page)	Changes
6	May. 10, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Nov. 12, 2018	Detail	Changes
3	Nov. 12, 2018	Detail	Changes
2	Oct. 02, 2018	Detail	Changes
1	Oct. 02, 2018	Detail

List of change history