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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015037
Receipt No. 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

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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
Email 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
Email harameg@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017499

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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