臨床研究等提出・公開システム

Date of registration	Sept. 21, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221243

Scientific Title	A Phase II/III Study to Assess the Safety and Immunogenicity of subcutaneous DNK-FLU in Healthy Japanese Children
Public Title	DNK-PEDFLU-2

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	DENKA SEIKEN Co., Ltd
	Address	+81-3-3662-2203
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DENKA SEIKEN Co., Ltd
	Address	+81-3-3662-2203
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		40
Study Type		Interventional
Study Design	Study Design	A multicenter, open-label study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Child
	Exclusion Criteria	Known history of influenza or received influenza vaccination within six months.
	Minimum Age	0age over
	Maximum Age	12age old under
	Gender	Both
Health Condition or Problem Studied		Prevention of influenza infection
Intervention(s)		investigational material(s) Generic name etc : DNK-FLU INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : subcutaneous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety and immunogenicity Adverse Event HI antibody titer against antigen
Secondary Outcome		immunogenicity Neutralizing antibody titer against influenza virus

Primary Sponsor	DENKA SEIKEN CO.,LTD.
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-101280
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Jan. 10, 2012	Detail	Changes
7	Jan. 10, 2012	Detail	Changes
6	May. 27, 2011	Detail	Changes
5	May. 27, 2011	Detail	Changes
4	Nov. 25, 2010	Detail	Changes
3	Nov. 25, 2010	Detail	Changes
2	Sept. 21, 2010	Detail	Changes
1	Sept. 21, 2010	Detail

List of change history