UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045551 |
|---|---|
| Receipt number | R000051993 |
| Scientific Title | Amount of antibody produced by COVID-19 vaccination of mRNA-1273(Takeda/Moderna) and BNT162b2(Pfizer/BioNTech) in Japanese youth. |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2022/03/25 09:25:57 |
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Basic information
Public title
Amount of antibody produced by new coronavirus vaccination of young Japanese people.
Acronym
Amount of antibody produced by vaccination of young people.
Scientific Title
Amount of antibody produced by COVID-19 vaccination of mRNA-1273(Takeda/Moderna) and BNT162b2(Pfizer/BioNTech) in Japanese youth.
Scientific Title:Acronym
Amount of antibody produced by COVID-19 vaccination of Japanese youth.
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate and report the amount of IgG antibody produced in the body when a young Japanese person is vaccinated with the new coronavirus vaccine.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IgG antibody level of new corona vaccinated person.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The following students of our university.
1. Among current students, persons over 18 years old who have received two doses of Pfizer's SARS-CoV-2 vaccine in and have been vaccinated for at least two weeks, and who can consent to donating a sample (50 persons).
2. Persons over 18 years old who have received two doses of Moderna's SARS-CoV-2 vaccine and have been vaccinated for at least two weeks, and who can consent to donating a sample (200 persons).
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Sugawara |
Organization
Nishikyushu University
Division name
Faculty of Health and Social Welfare Sciences
Zip code
842-8585
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga
TEL
0952-52-4191
sugawarama@nisikyu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hisatomi |
Organization
Nishikyushu University
Division name
Installation preparation room and Faculty of Health and Nutrition Sciences
Zip code
842-8585
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga
TEL
0952-52-4191
Homepage URL
hisatomiyu@nisikyu-u.ac.jp
Sponsor or person
Institute
Nishikyushu University
Institute
Department
Personal name
Funding Source
Organization
Nishikyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishikyushu University
Address
4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga
Tel
0952-52-4191
syomu@nisikyu-u.ac.jp
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 | 09 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study compares vaccination-induced antibody production in adolescents with studies in Japan.
Management information
Registered date
| 2021 | Year | 09 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051993
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
