UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053072 |
|---|---|
| Receipt number | R000060500 |
| Scientific Title | Immune Persistence and Safety Cohort Survey on Booster vaccination of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2024/04/16 20:35:29 |
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Basic information
Public title
Immune Persistence and Safety Cohort Survey on Booster vaccination of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan
Acronym
Immune Persistence and Safety Cohort Survey on Booster Vaccination the New SARS-CoV-2 Vaccine in Japan
Scientific Title
Immune Persistence and Safety Cohort Survey on Booster vaccination of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan
Scientific Title:Acronym
Immune Persistence and Safety Cohort Survey on Booster Vaccination the New SARS-CoV-2 Vaccine in Japan
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Immune Persistence and Safety Cohort Survey on Booster vaccination of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety up to 4 weeks after booster vaccination recipients of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan
Key secondary outcomes
Breakthrough infection rate up to 12 months after the last SARS-CoV-2 vaccination
Serious adverse events up to 12 months after vaccination (regardless of causality)
Changes in COVID-19 antibody titer up to 12 months after vaccination (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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals aged 12 years or older who have completed their initial SARS-CoV-2 vaccination and have received an additional dose of the after the specified vaccination interval since their previous vaccination.
2)Individuals who require blood sampling for antibody titer determination should, in principle, be able to visit the relevant medical institution for a minimum 6-month survey period. For those participating solely in the survey, the survey form can be submitted by mail.3)
3)Vaccinated individuals with written consent:
For those aged 12 to 15: Individuals who have received an explanation of the research and have provided informed assent with written informed consent from a parent or guardian.
For those aged 16 to 17: Individuals who have received an explanation of the research and have provided informed consent, along with written informed consent from a parent or guardian.
For those 18 years of age or older: Individuals who have provided written informed consent for participation in the research study.
Key exclusion criteria
Those who are inappropriate as the subject of the survey determined by the principal investigator
Target sample size
3000
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 JAPAN
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
Division name
Clinical Research and Trial Center, Juntendo University Hospital
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 JAPAN
TEL
03-3813-3111
Homepage URL
covidvac@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
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
Tokyodo Chiyoda Bldg. 15F, 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
順天堂大学医学部附属順天堂医院(東京都),独立行政法人国立病院機構高崎総合医療センター(群馬県),独立行政法人国立病院機構佐賀病院(佐賀県),独立行政法人国立病院機構神戸医療センター(兵庫県),独立行政法人国立病院機構下総精神医療センター(千葉県),独立行政法人国立病院機構宇多野病院(京都府),独立行政法人国立病院機構大阪南医療センター(大阪府),独立行政法人地域医療機能推進機構中京病院(愛知県),独立行政法人国立病院機構南岡山医療センター(岡山県),順天堂大学医学部附属練馬病院(東京都),独立行政法人国立病院機構近畿中央呼吸器センター(大阪府),独立行政法人国立病院機構金沢医療センター(石川県),独立行政法人国立病院機構小倉医療センター(福岡県),独立行政法人国立病院機構とくしま医療センター西病院(徳島県),独立行政法人国立病院機構災害医療センター(東京都),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
| 2023 | Year | 12 | Month | 12 | 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
300
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
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Primary outcomes:
Safety up to 4 weeks after booster vaccination recipients of the Newly developed SARS-CoV-2 Omicron Strain XBB.1.5 Vaccine in Japan
Secondary outcomes:
Breakthrough infection rate up to 12 months after the last SARS-CoV-2 vaccination
Serious adverse events up to 12 months after vaccination (regardless of causality)
Changes in COVID-19 antibody titer up to 12 months after vaccination (some of the survey subjects)
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060500
| 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 |
