UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of immunogenicity of monovalent inactivated influenza vaccine contained Saitama strain with it contained Hong Kong strain
Acronym	Comparison of immunogenicity of monovalent inactivated influenza vaccine contained Saitama strain with it contained Hong Kong strain
Scientific Title	Comparison of immunogenicity of monovalent inactivated influenza vaccine contained Saitama strain with it contained Hong Kong strain
Scientific Title:Acronym	Comparison of immunogenicity of monovalent inactivated influenza vaccine contained Saitama strain with it contained Hong Kong strain
Region	Japan

Condition
Condition	Prevention of influenza
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Administer monovalent inactivate influenza vaccine contained Saitama strain or Hong Kong strain to healthy subject, to compare; - antibody response against study vaccine strains, - antibody response against circulated stains
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1, Immunogenicity Antibody titer against study vaccine strains and circulated strains
Key secondary outcomes	2. Safety Adverse event and side effect occurred within one week after vaccination.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	Subcutaneous injections of monovalent inactivated influenza vaccine contained Saitama strain (0.5mL) into subjects arms
Interventions/Control_2	Subcutaneous injections of monovalent inactivated influenza vaccine contained Honk Kong strain (0.5mL) into subjects
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects who; 1. Provide written consent 2. Male or Female over 20 years old. 3. Are not vaccinated 2017-18 seasonal influenza vaccine. 4. Do not plan to get vaccinated seasonal influenza vaccine until completion of blood sample collection scheduled 3 weeks after vaccination.
Key exclusion criteria	Subjects who; 1. have fever. 2. have sever acute disease 3. are allergic to substance of study vaccine, eggs, chicken, or any derivative of chicken . 4. are vaccinated live vaccine within 27 days, or inactivated vaccine within 6 days. 5. are judged not appropriate for this study by study physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshio Hirota
Organization	SOUSEIKAI Clinical Epidemiological Research Center
Division name	Center Director
Zip code
Address	3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL	092-662-3608
Email	junko-manabe@lta-med.com

Public contact
Name of contact person	1st name Middle name Last name Hiroko Kumashiro
Organization	SOUSEIKAI Hakata Clinic
Division name	Planning & Coordination Dept.
Zip code
Address	Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka,812-0025
TEL	0922837701
Homepage URL
Email	hiroko-kumashiro@lta-med.com

Sponsor
Institute	SOUSEIKAI Clinical Epidemiological Research Center
Institute
Department

Funding Source
Organization	MHLW
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	SOUSEIKAI PS Clinic Osaka Institute of Public Health Department of Public Health, Osaka City University Graduate School of Medicine
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	医療法人相生会ピーエスクリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 26 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	2017 Year 09 Month 07 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2017 Year 11 Month 10 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 26 Day
Last modified on	2019 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033492