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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037009
Receipt No. 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 2019/12/10

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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
Email terauchi-koc@umin.ac.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
Email terauchi-koc@umin.ac.jp

Sponsor
Institute Department of Pediatrics, Kochi Medical School
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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