臨床研究等提出・公開システム

Date of registration	July. 16, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222144

Scientific Title	Exploratory clinical trial of KIB-PCI in healthy Japanese children
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	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	Single-center, uncontrolled, open-label study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1) healthy Japanese children
	Exclusion Criteria	1) Subjects with history of H5N1 influenza 2) Subjects with history of H5N1 influenza vaccination
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of new type of influenza infection
Intervention(s)		investigational material(s) Generic name etc : KIB-PCI INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : intramuscular
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		SRH antibody titer
Secondary Outcome		HI antibody titer Neutralizing antibody titer

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor	KITASATO DAIICHI SANKYO VACCINE COMPANY, LIMITED

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-132190
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Nov. 02, 2016	Detail	Changes
7	Nov. 01, 2016	Detail	Changes
6	Jan. 27, 2014	Detail	Changes
5	Jan. 27, 2014	Detail	Changes
4	Oct. 21, 2013	Detail	Changes
3	Oct. 21, 2013	Detail	Changes
2	July. 16, 2013	Detail	Changes
1	July. 16, 2013	Detail

List of change history