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Jan. 20, 2020

Nov. 30, 2021

jRCT2080225025

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

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

Aug. 11, 2020

Yes

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/

version:
date:

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Feb. 01, 2020

100

Interventional

multicenter, randomized, observer-blinded

prevention purpose

3

Japanese healthy children of 12 months and older and younger than 24 months

- 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

12month old over
23month old under

Both

Prophylaxis of measles, mumps, and rubella

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 : -

efficacy
- Seroprotection rate of anti-measles virus antibody
- Seroprotection rate of anti-rubella virus antibody
- Seroprotection rate of anti-mumps virus antibody

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

DAIICHI SANKYO Co.,Ltd.
-
-
-
Kitamachi ethic committee
1-1-3, Kichijoji Kitamachi, Musashino city, Tokyo

approved

Dec. 20, 2019

JapicCTI-205117
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