臨床研究等提出・公開システム

Date of registration	Jan. 20, 2020
Last modified on	Nov. 30, 2021
Trial ID	jRCT2080225025

Scientific Title	A Phase 3, Randomized, Observer-blinded Study of Low and High titer JVC-001 in Healthy Japanese Children 1 Year of Age
Public Title	A Phase 3, Randomized, Observer-blinded Study of Low and High titer JVC-001 in Healthy Japanese Children 1 Year of Age

Completion Date or Terminated date	Aug. 11, 2020
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	Yes
Plan description	Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Feb. 01, 2020
Target Sample Size		100
Study Type		Interventional
Study Design	Study Design	multicenter, randomized, observer-blinded
Study Design	Objective	prevention purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese healthy children of 12 months and older and younger than 24 months
	Exclusion Criteria	- Subjects with history of measles, mumps, or rubella infection - Subjects with measles, mumps, or rubella infection - Subjects with history of measles, mumps, or rubella virus vaccination
	Minimum Age	12month old over
	Maximum Age	23month old under
	Gender	Both
Health Condition or Problem Studied		Prophylaxis of measles, mumps, and rubella
Intervention(s)		investigational material(s) Generic name etc : freeze-dried live attenuated measles, mumps, rubella combined vaccine INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : subcutaneous injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy - Seroprotection rate of anti-measles virus antibody - Seroprotection rate of anti-rubella virus antibody - Seroprotection rate of anti-mumps virus antibody
Secondary Outcome		efficacy - Seroconversion rate and GMT of anti-measles virus antibody - Seroconversion rate and GMT of anti-rubella virus antibody - Seroconversion rate, seroresponse rate, and GMT of anti-mumps virus antibody

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Kitamachi ethic committee
Address of IRB	1-1-3, Kichijoji Kitamachi, Musashino city, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Dec. 20, 2019

Secondary ID No.	JapicCTI-205117
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Nov. 30, 2021	(this page)	Changes
3	Dec. 02, 2020	Detail	Changes
2	Oct. 01, 2020	Detail	Changes
1	Jan. 21, 2020	Detail

List of change history