UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024388 |
|---|---|
| Receipt number | R000025694 |
| Scientific Title | Studies on effectiveness and safety of vaccination with H5N1 prepandemic vaccines, and cross-immunity among H5N1 viruses |
| Date of disclosure of the study information | 2016/10/13 |
| Last modified on | 2018/06/19 13:31:01 |
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Basic information
Public title
Studies on effectiveness and safety of vaccination with H5N1 prepandemic vaccines, and cross-immunity among H5N1 viruses
Acronym
Tests on vaccination with H5N1 prepandemic vaccines
Scientific Title
Studies on effectiveness and safety of vaccination with H5N1 prepandemic vaccines, and cross-immunity among H5N1 viruses
Scientific Title:Acronym
Tests on vaccination with H5N1 prepandemic vaccines
Region
| Japan |
Condition
Condition
Inoculation with H5N1 prepandemic vaccines
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating whether antibodies against H5N1 influenza hemagglutinins induced by innoculation with 4 kinds of H5N1 prepandemic vaccine have cross-reactivity with the hemagglutinins.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-reactivity of anti-hemagglutinin antibodies with hemagglutinins of H5N1 influenza viruses about 7 weeks after vaccination.
Key secondary outcomes
Safety of inoculation with H5N1 prepandemic vaccines.
Systemic reactions:
fever of more than 37.5 degree celsius, headache, general fatigue.
Local reactions at inoculated site:
redness, swelling, induration, pain, heat sensation, itching.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Vaccination: twice
Interval: 3 weeks
Amouunt: 0.5 ml
Blood collection: before vaccination and 1 month later after the 2nd vaccination
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese persons who consent to participation in this study after comprehension of the study.
Key exclusion criteria
1) A person who clearly had a history of anaphylaxis to food or drugs.
2) A person who possibly have allergy to chicken eggs, chicken meet, and something derived from chicken.
3) A person who was diagnosed with immunodeficiency syndrome, or who has relatives with congenital immunodeficiency.
4) A person who has severe cardiovascular, hematological, respiratory, hepatic, renal, gastrointestinal, or psychoneuronal disorders.
5) A person who has previous history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
6) A person with respiratory diseases including interstitial pneumonia or bronchial asthma.
7) A person who received investigational and experimental drugs for other clinical trials within 4 months of entry.
8) A person who received live attenuated vaccines within 27 days of entry or inactivated vaccines and toxoids within 6 days of entry.
9) A person who is pregnant, is suspected to be pregnant, or a woman with breast-feeding.
10) A woman who received intravenous immunoglobulin (IVIG) or blood transfusion within 3 months of entry or who received IVIG more than 200 mg/kg within 6 months of entry.
11) A person whom researchers and doctors in charge of this study judge unsuitable for this clinical trial.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kurosawa |
Organization
Fujita Health University
Division name
Center for Research Promotion and Support
Zip code
Address
1-98 Kutsukakechou Dengakugakubo, Toyoake, Aichi 470-1192
TEL
0562-93-9387
kurosawa@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kurosawa |
Organization
Fujita Health University
Division name
Center for Research Promotion and Support
Zip code
Address
1-98 Kutsukakechou Dengakugakubo, Toyoake, Aichi 470-1192
TEL
0562-93-9387
Homepage URL
kurosawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Biken
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
藤田保健衛生大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025694
