UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045978 |
|---|---|
| Receipt number | R000052481 |
| Scientific Title | Consideration of antibody production after COMINATY booster inoculation |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2022/09/09 14:55:53 |
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Basic information
Public title
Consideration of antibody production after COMINATY booster inoculation
Acronym
booster
Scientific Title
Consideration of antibody production after COMINATY booster inoculation
Scientific Title:Acronym
booster
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It's the purpose of this research to make the antibody positive rate by the new-style coronavirus vaccine booster inoculation, the related gene of antibody production and the gene related to an antibody value change clear. I can think these inspection results will be necessary for future's new-style coronavirus measure and, are some help.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The antibody positive rate which is 3 months after COMINATY booster inoculation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)the staff who took booster inoculation of COMINATY in Kamagaya general hospital
2)the way where the age of the time of the agreement merit is more than 20 years old(I don't ask about gender.)
3)the back and the way where documentary consent by free will of the patient person himself was got where I had the enough explanation in case of participation of this research
Key exclusion criteria
The parson who judged that a study person in charge was unsuitable as a subject of research person
Target sample size
674
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
ORTHOPEDIC SURGERY
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8266
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
ORTHOPEDIC SURGERY
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8266
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address
Emina Building 3F,1-8-7 Koji-machi,Chiyoda-ku,Tokyo
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 20 | 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
367
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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After agreement acquisition of a study, I test an antibody as of 1,3,6,9,12 months after booster inoculation of COMINATY.
Management information
Registered date
| 2021 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052481
