臨床研究等提出・公開システム

Date of registration	Nov. 17, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221313

Scientific Title	Immunogenicity and Safety of the DTaP-IPV (sanofi Pasteur Kitasato) Combined Vaccine (DD-687) given subcutaneously as a three-dose primary and booster vaccination versus commercially available DTaP (Kitasato) and Oral Polio Virus (OPV) Vaccines in Infants in Japan
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		374
Study Type		Interventional
Study Design	Study Design	Multi-center, double-blind, randomized, controlled, phase III, two-arm, unbalanced, clinical study.
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	starting at 3-68 (recommended 3-8) months of age
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection.
Intervention(s)		investigational material(s) Generic name etc : DD-687 INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Subcutaneous injection control material(s) Generic name etc : DTaP, Oral Polio Vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Subcutaneous injection, Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Immunogenicity anti-Polio 1, 2 and 3 antibody titers
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd., Sanofi Aventis KK
Secondary Sponsor	The Kitasato Institute, Sanofi Pasteur KK, Sanofi Pasteur SA

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-101350
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
15	Dec. 17, 2018	(this page)	Changes
14	July. 08, 2015	Detail	Changes
13	July. 08, 2015	Detail	Changes
12	July. 08, 2015	Detail	Changes
11	July. 08, 2015	Detail	Changes
10	Mar. 01, 2013	Detail	Changes
9	Mar. 01, 2013	Detail	Changes
8	Feb. 15, 2012	Detail	Changes
7	Feb. 15, 2012	Detail	Changes
6	Feb. 07, 2011	Detail	Changes
5	Feb. 07, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Nov. 17, 2010	Detail	Changes
1	Nov. 17, 2010	Detail

List of change history