臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 15, 2010
Last modified on	Oct. 24, 2013
Trial ID	jRCT1090220048

Scientific Title	Clinical study using preserved serum samples obtained in clinical trials of absorbed influenza vaccine (H5N1). (FLU-PPV-AD)
Public Title	Clinical study using preserved serum samples obtained in clinical trials of absorbed influenza vaccine (H5N1).

Study end date	Mar. 30, 2011
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Hitoshi Kamiya
	Investigator Organization	National Hospital Organization Mie National Hospital
	Address	357-Kubota Ozato Tsu Mie 514-0125,Japan
	TEL	+81-59-232-2531
	E-mail
Contact for Public Queries	Contact Name	Miwa Izutsu
	Contact Organization	CTD inc.
	Address	4-1-12 Tsukiji,Chuo-ku,Tokyo 104-0045,Japan
	TEL	+81-3-6228-4835
	E-mail	mizutsu@c-ctd.co.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Oct. 15, 2010
Planned Number of Subjects		350
Nature of Investigation		Observational
Study Design	Description of Trial Design	OBSERVATIONAL
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who participated in one of the following clinical trials of influenza vaccine: BK-PIFA/002, KIB-PIA02, BK-PIFA003, or KIB-PIA03. Subjects must also meet the following conditions: 1) Subjects who consented to this study or subjects for whom the use of their serum samples in this study has been approved by the ethics committee and representatives of the study institution. 2) Subjects whose serum samples are available.
	Exclusion Criteria	None
	Minimum Age	6month old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		H5N1 influenza
Intervention(s)		Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Determination of possible pyrogenic substances.
Secondary Outcome(s)

Primary Sponsor	National Hospital Organization Mie National Hospital
Secondary Sponsor

Sources of funding	Ministry of Health, Labour and Welfare

Name of Ethics Committee
Address
TEL
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Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved

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Secondary Study ID	JMA-IIA00048
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Oct. 24, 2013	(this page)	Changes
1	Oct. 15, 2010	Detail

List of change history