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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029293
Receipt No. R000033492
Scientific Title Comparison of immunogenicity of monovalent inactivated influenza vaccine contained Saitama strain with it contained Hong Kong strain
Date of disclosure of the study information 2017/09/26
Last modified on 2017/11/07

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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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
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
2017 Year 11 Month 07 Day


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

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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