UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019797 |
|---|---|
| Receipt number | R000022876 |
| Scientific Title | Interchangeability of hepatitis A vaccines for children |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2019/03/30 13:43:55 |
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Basic information
Public title
Interchangeability of hepatitis A vaccines for children
Acronym
Interchangeability of hepatitis A vaccines for children
Scientific Title
Interchangeability of hepatitis A vaccines for children
Scientific Title:Acronym
Interchangeability of hepatitis A vaccines for children
Region
| Japan |
Condition
Condition
Hepatitis A
Classification by specialty
| Infectious disease | Pediatrics | Child |
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 HAVRIX720 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
Immunogenicity: Anti-HAV antibody
Anti-HAV antibody will be measured on days 0 and 28 after vaccination of HAVRIX720.
Key secondary outcomes
Safety
Adverse events will be documented by the sublects.
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 HAVRIX720(0.5ml, 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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy children
Key exclusion criteria
acute febrile illness
immunodeficiency
allergy against vaccine contents
history of hepatitis A
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
Address
6-7-1 Nishishinjuku shinjuku, Tokyo
TEL
03-3342-6111
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/
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022876
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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