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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044261
Receipt No. R000050555
Scientific Title Consideration of antibody production of a COMIRNATY intramuscular injection
Date of disclosure of the study information 2021/06/07
Last modified on 2021/06/07

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Basic information
Public title Consideration of antibody production of a COMIRNATY intramuscular injection
Acronym COMIRNATY
Scientific Title Consideration of antibody production of a COMIRNATY intramuscular injection
Scientific Title:Acronym COMIRNATY
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 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 COMIRNATY intramuscular injection
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 inoculation of a COMIRNATY intramuscular injection in Kamagaya general hospital (I don't ask about the number of times.)
2) the way where the age of the time of the agreement merit is more than 20 years old (I don't ask about the 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 person who judged that a study person in charge was unsuitable as a subject of research person
Target sample size 551

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Mochizuki
Organization Kamagaya General Hospital
Division name Plastic surgery
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8266
Email chiken@kamagaya-hp.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Mochizuki
Organization Kamagaya General Hospital
Division name Plastic surgery
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8266
Homepage URL
Email chiken@kamagaya-hp.jp

Sponsor
Institute Kamagaya General Hospital
Institute
Department

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
Email 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 06 Month 07 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 Enrolling by invitation
Date of protocol fixation
2021 Year 06 Month 30 Day
Date of IRB
2021 Year 06 Month 04 Day
Anticipated trial start date
2021 Year 06 Month 04 Day
Last follow-up date
2022 Year 06 Month 30 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 3 or 6 or 9 or 12 months and consider a yes or no of an antibody and the related factor after inoculation of the 1st time of COMIRNATY intramuscular injection.

Management information
Registered date
2021 Year 05 Month 19 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050555

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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