臨床研究等提出・公開システム

Date of registration	June. 01, 2018
Last modified on	April. 24, 2020
Trial ID	jRCT1080223928

Scientific Title	One year follow-up study of healthy adults who received one injection of live attenuated varicella vaccine
Public Title	One year follow-up study of healthy adults who received one injection of live attenuated varicella vaccine

Completion Date or Terminated date	Mar. 15, 2019
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	July. 29, 2019
URL hyperlink(s) related to results and publications	https://www.sciencedirect.com/science/article/pii/S0264410X19309892?via%3Dihub

Plan to share IPD	Undecided
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	BIKEN
	Address	3-1 Yamada-Oka, Suita, Osaka 565-0871, Japan
	Phone Number	+81-6-6877-4825
	E-mail Address	mahmad@mail.biken.or.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	BIKEN
	Address	3-1 Yamada-Oka, Suita, Osaka 565-0871, Japan
	Phone Number	+81-6-6877-4825
	E-mail Address	mahmad@mail.biken.or.jp

Recruitment Status	completed

Date of First Enrolment		June. 04, 2018
Target Sample Size		80
Study Type		Observational
Study Design	Study Design	Observational, prospective cohort study
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	volunteers who participated in previous VZV vaccine study (JAPIC CTI-173532)
	Exclusion Criteria	-
	Minimum Age	50age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		protection against Herpes Zoster
Intervention(s)		investigational material(s) Generic name etc : Oka/Biken live attenuated varicella zoster vaccine INN of investigational material : Freeze-dried Live Attenuated Varicella Vaccine Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Reconstitute the vaccine in 0.7 mL of the attached solvent (Water for injection , JP grade), and administer 0.5-mL dose by subcutaneous injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		exploratory Flowcytometric analyses of VZV CD4 memory cell response
Secondary Outcome		confirmatory Confirming the state of VZV specific antibody using EIA

Primary Sponsor	The Research Foundation For Microbial Diseases of Osaka University
Secondary Sponsor	Takei Clinic, Ohno Clinic, Iwamoto Medical Clinic

Name of Funding Organization	The Research Foundation for Microbial Diseases of Osaka University
Name of Research Funding	-

Name	Biken Institutional Ethical Review Board
Address	4-1-70 Seto-cho, Kanonji, Kagawa 768-0065, Japan
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	Feb. 21, 2018

Secondary ID No.	JapicCTI-183985
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	April. 24, 2020	(this page)	Changes
2	Mar. 26, 2019	Detail	Changes
1	June. 01, 2018	Detail

List of change history