UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029293 |
|---|---|
| Receipt number | 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 | 2019/09/13 10:11:48 |
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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
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
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Clinical Epidemiological Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033492
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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