UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on effectiveness and safety of vaccination with H5N1 prepandemic vaccines, and cross-immunity among H5N1 viruses
Title of the study (Brief title)	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	Yoshikazu Kurosawa
Organization	Fujita Health University
Division name	Center for Research Promotion and Support
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	Yoshikazu Kurosawa
Organization	Fujita Health University
Division name	Center for Research Promotion and Support
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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