臨床研究等提出・公開システム

Date of registration	Oct. 20, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223352

Scientific Title	Phase II study of BK1304 in healthy adults
Public Title

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	The Research Foundation For Microbial Diseases Of Osaka University
	Address	06-6877-4812
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		600
Study Type		Interventional
Study Design	Study Design	observer-blind
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Written informed consent is obtained from subject
	Exclusion Criteria
	Minimum Age	20age 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
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy
Secondary Outcome		Immunogenicity, Safety

Primary Sponsor	The Research Foundation For Microbial Diseases Of Osaka University
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-163407
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
6	Dec. 17, 2018	(this page)	Changes
5	Aug. 03, 2018	Detail	Changes
4	Aug. 03, 2018	Detail	Changes
3	Oct. 24, 2016	Detail	Changes
2	Oct. 20, 2016	Detail	Changes
1	Oct. 20, 2016	Detail

List of change history