UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047368 |
|---|---|
| Receipt number | R000053936 |
| Scientific Title | Immune Persistence and Safety Pediatric Survey (Aged 5-11 Years) related to the SARS-CoV-2 Vaccination (Primary series and Booster Vaccination) in Japan |
| Date of disclosure of the study information | 2022/04/02 |
| Last modified on | 2024/04/03 14:40:43 |
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Basic information
Public title
Immune Persistence and Safety Pediatric Survey (Aged 5-11 Years) related to the SARS-CoV-2 Vaccination (Primary series and Booster Vaccination) in Japan
Acronym
Immune Persistence and Safety Pediatric Cohort Survey on SARS-CoV-2 Vaccination in Japan
Scientific Title
Immune Persistence and Safety Pediatric Survey (Aged 5-11 Years) related to the SARS-CoV-2 Vaccination (Primary series and Booster Vaccination) in Japan
Scientific Title:Acronym
Immune Persistence and Safety Pediatric Cohort Survey on SARS-CoV-2 Vaccination in Japan
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and Immune Persistence of SARS-CoV-2 Vaccine in Children Aged 5 to 11 Years Old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety up to 4 weeks after the last vaccination of SAR S-CoV-2 vaccine
Key secondary outcomes
1) Breakthrough infection rate up to 6 months after the final vaccination of SARS-CoV-2 vaccine.
2) Serious adverse events up to 6 months after the final vaccination of SARS-CoV-2 vaccine (regardless of causality).
3) Changes in COVID-19 antibody titer up to 6 months after the final vaccination of SARS-CoV-2 vaccine (some of the survey subjects).
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
| 5 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Children aged 5 to 11 who received the initial or additional dose of the Pfizer vaccine.
2)Children aged 6 to 11 who received an additional dose of the Moderna vaccine.
3)Regarding the initial series vaccination survey, it targets children who are eligible to participate in the survey from the first dose (aged 5 to 11 at the time of the first dose).
4)Concerning the additional dose (third dose and beyond) vaccination survey, it targets children who can continue to participate from the initial series vaccination survey and children who are eligible to participate in the survey from the additional dose (aged 5 to 11 for Pfizer vaccine and 6 to 11 for Moderna vaccine).
5)Generally, for children aged approximately 5 to 6 (preschoolers, depending on their understanding), after explaining the research study, their willingness to participate is confirmed, and informed consent from the legal guardian is obtained.
6)For children aged 6 to 11 (elementary school students), after explaining the research study, informed assent (typically Assent Document A for grades 1 to 3 and Assent Document B for grades 4 to 6) is obtained from the child, and informed consent is obtained from the legal guardian.
Key exclusion criteria
Those who are inappropriate as the subject of the survey determined by the principal investi gator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Suminobu |
| Middle name | |
| Last name | Ito |
Organization
Juntendo University
Division name
Medical Technology Innovation Center
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 JA PAN
TEL
03-3813-3111
sito@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Morikuni |
| Middle name | |
| Last name | Tobita |
Organization
SARS-CoV-2 vaccine Research Secretariat, Juntendo University
Division name
Clinical Research and Trial Center, Juntendo University Hospital
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 JA PAN
TEL
03-3813-3111
Homepage URL
https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/
covidvac@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Welfare and Labor Administration Promotion Survey Project
Emerging / re-emerging infectious diseases and vaccination policy promotion research project
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@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
かずえキッズクリニック(東京都),医療法人社団 はやしクリニック(東京都),国立病院機構東京医療センター(東京都),順天堂大学医学部附属順天堂医院(東京都),順天堂大学医学部附属浦安病院(千葉県),順天堂大学医学部附属練馬病院(東京都),順天堂大学医学部附属静岡病院(静岡県),地域医療機能推進機構秋田病院(秋田県),地域医療機能推進機構諫早総合病院(長崎県),国立病院機構長崎医療センター(長崎県),国立病院機構三重病院(三重県),国立病院機構相模原病院(神奈川県),自治医科大学附属病院(栃木県),国立病院機構新潟病院(新潟県),国立病院機構岡山医療センター(岡山県),国立病院機構三重中央医療センター(三重県),順天堂大学医学部附属静岡病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/
Publication of results
Partially published
Result
URL related to results and publications
https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/
Number of participants that the trial has enrolled
411
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
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 01 | Day |
Other
Other related information
Interim reports have been repeatedly made at the Ministry of Health, Labor and Welfare, Health Science Council, Immunization and Vaccine Subcommittee, Adverse Reactions Examination Committee, etc.
From September 20, 2023, a monovalent vaccine for Omicron strain XBB.1.5 will be used for initial and booster vaccinations.
Management information
Registered date
| 2022 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053936
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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