UMIN-CTR Clinical Trial

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	370
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	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	2021 Year 12 Month 28 Day
Date of closure to data entry	2021 Year 12 Month 28 Day
Date trial data considered complete	2021 Year 12 Month 28 Day
Date analysis concluded	2021 Year 12 Month 28 Day

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	2022 Year 02 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050555