臨床研究等提出・公開システム

Date of registration	June. 23, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222536

Scientific Title	Clinical trial of VN-0104 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	DAIICHISANKYO 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		50
Study Type		Interventional
Study Design	Study Design	Single-center, uncontrolled, open-label study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese healthy adult volunteers
	Exclusion Criteria	1) Subjects with history of seasonal influenza in the past 6 months 2) Subjects with history of seasonal influenza vaccination in the past 6 months
	Minimum Age	20age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of influenza infection
Intervention(s)		investigational material(s) Generic name etc : VN-0104(Seasonal influenza quadrivalent vaccine) 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 endpoints: adverse events, body temperature Immunology endpoints: HI antibody titer, SRH antibody titer, Neutralizing antibody titer
Secondary Outcome

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-142587
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Feb. 18, 2015	Detail	Changes
5	Feb. 18, 2015	Detail	Changes
4	Jan. 27, 2015	Detail	Changes
3	Nov. 19, 2014	Detail	Changes
2	June. 23, 2014	Detail	Changes
1	June. 23, 2014	Detail

List of change history