UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052238 |
|---|---|
| Receipt number | R000059630 |
| Scientific Title | Immune Persistence and Safety Survey regarding Initial and Booster Vaccination of Monovalent Vaccine for SARS-CoV-2 Omicron Strain XBB.1.5 (Cohort Study) in Japan |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2025/04/07 14:18:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immune Persistence and Safety Survey regarding Initial and Booster Vaccination of Monovalent Vaccine for SARS-CoV-2 Omicron Strain XBB.1.5 (Cohort Study) in Japan
Acronym
Immune Persistence and Safety Cohort Survey on SARS-CoV-2 XBB Strain Initial and Booster Vaccination in Japan
Scientific Title
Immune Persistence and Safety Survey regarding Initial and Booster Vaccination of Monovalent Vaccine for SARS-CoV-2 Omicron Strain XBB.1.5 (Cohort Study) in Japan
Scientific Title:Acronym
Immune Persistence and Safety Cohort Survey on SARS-CoV-2 XBB Strain Initial and Booster Vaccination 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
Safety and Immune Persistence on Initial and Booster Vaccination for the SARS-CoV-2 XBB strain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety up to 4 weeks after initial or booster recipients of SARS-CoV-2 vaccine for XBB strain
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
Initial Vaccination Recipient:
1) Individuals aged 12 years or older who have never received a COVID-19 vaccine and are receiving their first dose of the monovalent Omicron strain XBB.1.5 vaccine, regardless of their infection history.
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)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.
Booster Vaccination Recipient:
1)Individuals aged 12 years or older who have completed their initial SARS-CoV-2 vaccination and have received an additional dose of the monovalent Omicron strain XBB.1.5 vaccine 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)Vaccinated individuals with written consent: The same as initial vaccination recipient.
Key exclusion criteria
Those who are inappropriate as the subject of the survey determined by the principal investigator
Target sample size
6500
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, 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 JAPAN
TEL
03-3813-3111
Homepage URL
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
国立病院機構函館病院(北海道),国立病院機構水戸医療センター(茨城県),国立病院機構高崎総合医療センター(群馬県),国立病院機構渋川医療センター(群馬県),国立病院機構千葉医療センター(千葉県),国立病院機構東京医療センター(東京都),国立病院機構村山医療センター(東京都),国立病院機構新潟病院(新潟県),国立病院機構信州上田医療センター(長野県),国立病院機構豊橋医療センター(愛知県),国立病院機構鈴鹿病院(三重県),国立病院機構三重中央医療センター(三重県),国立病院機構南京都病院(京都府),国立病院機構大阪医療センター(大阪府),国立病院機構神戸医療センター(兵庫県),国立病院機構鳥取医療センター(鳥取県),国立病院機構岡山医療センター(岡山県),国立病院機構広島西医療センター(広島県),国立病院機構東広島医療センター(広島県),国立病院機構大牟田病院(福岡県),国立病院機構長崎医療センター(長崎県),国立病院機構熊本再春医療センター(熊本県),医療機能推進機構中京病院(愛知県),医療機能推進機構諫早総合病院(長崎県),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練馬病院(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静岡病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 20 | 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
3391
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
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | 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
Safety up to 4 weeks after initial or booster recipients of SARS-CoV-2 vaccine for XBB strain.
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 | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059630
