臨床研究等提出・公開システム

Date of registration	Mar. 10, 2017
Last modified on	April. 06, 2020
Trial ID	jRCT1080223477

Scientific Title	Investigation of cell mediated immune response induced by varicella vaccine
Public Title	Investigation of cell mediated immune response induced by varicella vaccine

Completion Date or Terminated date	Nov. 30, 2017
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		April. 10, 2017
Target Sample Size		80
Study Type		Observational
Study Design	Study Design	Observatory, Prospective cohort study
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Varicella vaccine applicants
	Exclusion Criteria	History of Herpes Zoster Confirmed history of immunodeficiency disease
	Minimum Age	50age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Prevention of 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 (BIKEN) 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 Correlation between varicella vaccination and VZV specific T-cells count
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
Secondary Sponsor	Ohno Clinic
Secondary Sponsor	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	Oct. 11, 2016

Secondary ID No.	JapicCTI-173532
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	April. 06, 2020	(this page)	Changes
6	Mar. 28, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Dec. 04, 2017	Detail	Changes
3	Dec. 04, 2017	Detail	Changes
2	Mar. 13, 2017	Detail	Changes
1	Mar. 10, 2017	Detail

List of change history