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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009351
Receipt No. R000010908
Scientific Title Interchangeability of hepatitis A vaccines
Date of disclosure of the study information 2012/11/19
Last modified on 2019/03/30

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Basic information
Public title Interchangeability of hepatitis A vaccines
Acronym Interchangeability of hepatitis A vaccines
Scientific Title Interchangeability of hepatitis A vaccines
Scientific Title:Acronym Interchangeability of hepatitis A vaccines
Region
Japan

Condition
Condition Hepatitis A
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the immunogenicity and tolerability of a single booster dose of Havrix after two doses of Aimmgen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Anti-HAV antibody:
Anti-HAV antibody will be measured on days 0 and 28 after vaccination of Havrix.
Key secondary outcomes Adverse event:
Averse events will be documented by the subjects.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Single dose of Havrix (1.0ml, IM)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healty volunteer
Key exclusion criteria acute febrile illness
immunodeficiency
allergy against vaccine contents
pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Fukushima
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code
Address 6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL 03-3342-6111
Email fuku789@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Fukushima
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code
Address 6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL 03-3342-6111
Homepage URL http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/
Email fuku789@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Infectious Diseases
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科大学病院(東京都)、国立感染症研究所(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 06 Month 05 Day
Date of IRB
2012 Year 06 Month 05 Day
Anticipated trial start date
2012 Year 11 Month 21 Day
Last follow-up date
2014 Year 07 Month 18 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 17 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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