UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009351 |
|---|---|
| Receipt number | R000010908 |
| Scientific Title | Interchangeability of hepatitis A vaccines |
| Date of disclosure of the study information | 2012/11/19 |
| Last modified on | 2023/01/01 11:17:11 |
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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 | Shinji |
| Middle name | |
| Last name | Fukushima |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL
0353393726
fuku789@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | SHINJI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL
0353393726
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
Tokyo Medical University
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
Tokyo Medical University
Address
6-7-1 Nishi Shinjuku
Tel
0353393726
IRB@tokyo-med.ac.jp
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
https://doi.org/10.1016/j.vaccine.2017.10.002
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.vaccine.2017.10.002
Number of participants that the trial has enrolled
20
Results
Aimmugen is a lyophilized inactivated aluminum-free hepatitis A vaccine (0, 2-4 weeks and 6 months).
Participants were twenty healthy Japanese travelers aged 20 years or older who had received two doses of Aimmugen.
They received a booster dose of Havrix1440 intramuscularly as the third dose.
The seroprotection rate was 85 % at pre-vaccination, and 100 % at post-vaccination of Havrix.
The geometric mean antibody titers increased from 39.8 mIU/mL to 2938 mIU/mL.
Results date posted
| 2023 | Year | 01 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were healthy Japanese adults aged 20 years or older who had received two doses of Aimmugen.
They were 6 male and 14 female. The mean age was 37.2.
Participant flow
Participants were healthy Japanese adults aged 20 years or older who had received two doses of Aimmugen.
They received a booster dose of Havrix1440 intramuscularly as the third dose.
Blood samples for hepatitis A virus antibody titers were taken 4 - 6 weeks later.
Anti-HAV antibody titers were measured by an inhibition enzyme linked immunosorbent assay.
Adverse events
No severe adverse events
Outcome measures
Immunogenicity was seroprotection rate and gean metric titers of anti-hepatitis A virus.
Blood samples for hepatitis A virus antibody titers were collected pre-vaccination and 4-6 weeks later.
Anti-hepatitis A virus antibody titers were measured by an inhibition enzyme-linked immunosorbent assay.
Seropositivity was anti-hepatitis A virus antibody titer more than 10 mIU/mL.
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
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010908
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