臨床研究等提出・公開システム

Date of registration	Sept. 20, 2016
Last modified on	Feb. 24, 2021
Trial ID	jRCT2080223323

Scientific Title	-
Public Title	-

Completion Date or Terminated date	June. 26, 2019
Actual Enrolled Number	3450
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	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	-
	Address	-
	Phone Number	-
	E-mail Address	clinical-trials@pfizer.com

Contact for Public Queries	Name
	Contact Name for Public Queries	-
	Address	-
	Phone Number	-
	E-mail Address	clinical-trials@pfizer.com

Recruitment Status	terminated

Date of First Enrolment		July. 02, 2015
Target Sample Size		2600
Study Type		Interventional
Study Design	Study Design	-
Study Design	Objective	prevention purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-
	Exclusion Criteria	-
	Minimum Age	18age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : - 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		safety efficacy -
Secondary Outcome		efficacy -

Primary Sponsor	-
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 12, 2016

Secondary ID No.	NCT02388165
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-163378
Name of Other Registries

Countries / Regions of Recruitment	Japan/North America/Europe

History of Changes

No	Publication date
5	Feb. 24, 2021	(this page)	Changes
4	Nov. 13, 2019	Detail	Changes
3	Mar. 08, 2019	Detail	Changes
2	Jan. 26, 2017	Detail	Changes
1	Sept. 20, 2016	Detail

List of change history