UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037009 |
|---|---|
| Receipt number | R000041903 |
| Scientific Title | Study of the long-term immunogenicity of a combined diphteria, tetanus, acellular pertussis with a Sabin strain derived inactivated poliovirus vaccine |
| Date of disclosure of the study information | 2019/06/17 |
| Last modified on | 2023/06/13 12:48:15 |
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Basic information
Public title
Study of the long-term immunogenicity of a combined diphteria, tetanus, acellular pertussis with a Sabin strain derived inactivated poliovirus vaccine
Acronym
Study of the long-term immunogenicity of a DTaP-sIPV
Scientific Title
Study of the long-term immunogenicity of a combined diphteria, tetanus, acellular pertussis with a Sabin strain derived inactivated poliovirus vaccine
Scientific Title:Acronym
Study of the long-term immunogenicity of a DTaP-sIPV
Region
| Japan |
Condition
Condition
healthy children
Classification by specialty
| Infectious disease | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the immunogenicity of a combined diphteria, tetanus, acellular pertussis with a Sabin strain derived inactivated poliovirus vaccine at 7 years after 4th vaccination
Basic objectives2
Others
Basic objectives -Others
To assess the antibody titer against poliovirus (type 1-3), Corynebacterium diphteria, Clostridium tetani, and Bordetella pertussis at 7 years after 4th vaccination
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
antibody titer against poliovirus (type 1-3)
Key secondary outcomes
antibody titer against Corynebacterium diphteria
antibody titer against Clostridium tetani
antibody titer against Bordetella pertussis
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
| 7 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants of the Japan Environment and Children's Study cohor at the Kochi Unit Center (detailed survey at 8 years old) who have agreed to cooperate with this research
Key exclusion criteria
Those fulfilling or suspected to fulfill any of the following criteria
1) With immune deficiency
2) Those who does not consent to participate in this research
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Terauchi |
Organization
Kochi Medical School
Division name
Pediatrics
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
TEL
088-866-5811
yoshihiko-t@outlook.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Terauchi |
Organization
Kochi Medical School
Division name
Pediatrics
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
TEL
088-866-5811
Homepage URL
yoshihiko-t@outlook.jp
Sponsor or person
Institute
Department of Pediatrics, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Integrated Center for Advanced Medical Technologies
Address
185-1, Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
Tel
088-880-2719
im62@kochi-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
| 2019 | Year | 06 | Month | 17 | 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
2138
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Cross-sectional study
Research of the antibody titer of the children at the age of 8
Management information
Registered date
| 2019 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
