UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044261
Receipt number 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 2022/02/05 11:31:00

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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 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

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

Value
https://center6.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