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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024388
Receipt No. 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

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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
Email 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
Email kurosawa@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025694

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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