UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015037 |
|---|---|
| Receipt number | R000017499 |
| Scientific Title | Immunogenicity, safety, and effectiveness of influenza vaccine among subject at high risk |
| Date of disclosure of the study information | 2014/09/03 |
| Last modified on | 2014/09/03 13:22:46 |
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Basic information
Public title
Immunogenicity, safety, and effectiveness of influenza vaccine among subject at high risk
Acronym
Immunogenicity, safety, and effectiveness of influenza vaccine among subject with severe motor and intellectual disability
Scientific Title
Immunogenicity, safety, and effectiveness of influenza vaccine among subject at high risk
Scientific Title:Acronym
Immunogenicity, safety, and effectiveness of influenza vaccine among subject with severe motor and intellectual disability
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunogenicity, safety and effectiveness of influenza vaccine in subject with severe motor and intellectual disability in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Immune response rates at 4 weeks after vaccination
Key secondary outcomes
Antibody efficacy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects with disability or their guardians provided written informed consent for their participation in this study
Key exclusion criteria
Exclusion criteria were follows: if they had any history of diphtheria, tetanus, and pertussis; if they had received any other drug or vaccine within 30 days of entry; if they had a history of allergic reactions to any vaccine component; if they had an acute disease or a febrile illness at the time of vaccination.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Hara |
Organization
Saga University
Division name
Department of Medicine
Zip code
Address
5-1-1 Nabeshima Saga-city, Saga, Japan
TEL
0952-34-2289
harameg@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Hara |
Organization
Saga University
Division name
Department of Medicine
Zip code
Address
5-1-1 Nabeshima Saga-city, Saga, Japan
TEL
0952-34-2289
Homepage URL
harameg@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 03 | 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
Immunogenicity post-vaccination did not meet European Medicines Evaluation Agency criteria.
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
| 2006 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
antibody efficacy: 71%, vaccine efficacy: 19%
Management information
Registered date
| 2014 | Year | 09 | Month | 03 | Day |
Last modified on
| 2014 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017499
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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