臨床研究等提出・公開システム

Date of registration	Sept. 20, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221923

Scientific Title	A randomized, double-blind, controlled study of KIB-PCI in Japanese healthy adult volunteers
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	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		800
Study Type		Interventional
Study Design	Study Design	A multicenter, randomized, double-blind, parallel-group, active-controlled study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1) Japanese healthy adult volunteers
	Exclusion Criteria	1) Subjects with a history of influenza A (H5N1) virus infection 2) Subjects who have received influenza A (H5N1) vaccine
	Minimum Age	20age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of new type of influenza virus 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 control material(s) Generic name etc : egg-derived influenza A (H5N1) vaccine 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 against H5 antigen
Secondary Outcome		HI antibody titer against H5 antigen Neutralizing antibody titer against H5N1 influenza virus

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-121968
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 16, 2015	Detail	Changes
7	Mar. 16, 2015	Detail	Changes
6	Mar. 12, 2015	Detail	Changes
5	Mar. 12, 2015	Detail	Changes
4	Oct. 11, 2013	Detail	Changes
3	Oct. 11, 2013	Detail	Changes
2	Sept. 20, 2012	Detail	Changes
1	Sept. 20, 2012	Detail

List of change history