臨床研究等提出・公開システム

Date of registration	May. 12, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222484

Scientific Title	VN-0103 Ph3 study -A randomized, observer-blind comparative study of VN-0103 and diphtheria-tetanus toxoid in Japanese adolescents
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		360
Study Type		Interventional
Study Design	Study Design	Multi-centered, active control, randomized, parallel-group controlled observer-blind study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1) Age 11 or 12 years on the day of injection. 2) Subjects who received 3 or more dose of acellular pertussis diphtheria tetanus vaccine. 3) Subjects who follow regulations, have an examination, and can report symptoms.
	Exclusion Criteria	1) Subjects who have fever (temperature ≥ 37.5°C) . 2) Subjects who have severe acute disease.
	Minimum Age	11age old over
	Maximum Age	12age old under
	Gender	Both
Health Condition or Problem Studied		For active immunization against pertussis, diphtheria and tetanus
Intervention(s)		investigational material(s) Generic name etc : VN-0103 (Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine) INN of investigational material : Therapeutic category code : 636 Mixed biological preparations Dosage and Administration for Investigational material : A single subcutaneously injection (0.5 mL). control material(s) Generic name etc : Diphtheria-tetanus toxoid INN of investigational material : Therapeutic category code : 636 Mixed biological preparations Dosage and Administration for Investigational material : A single subcutaneously injection (0.1 mL).
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Booster response rates against pertussis toxoid, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid
Secondary Outcome		Antibody prevalence rate, Seroconversion rate, Geometric mean titer, Geometric mean titer ratio

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-142535
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	June. 01, 2015	Detail	Changes
7	June. 01, 2015	Detail	Changes
6	Oct. 16, 2014	Detail	Changes
5	Oct. 16, 2014	Detail	Changes
4	July. 03, 2014	Detail	Changes
3	July. 03, 2014	Detail	Changes
2	May. 12, 2014	Detail	Changes
1	May. 12, 2014	Detail

List of change history