UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010779 |
|---|---|
| Receipt number | R000012612 |
| Scientific Title | Transition of Anti-pertussis Antibodies and the Safety of Japanese Diphteria-acellular Pertussis-Tetanus Vaccine administered in reduced doses among Adults |
| Date of disclosure of the study information | 2013/06/06 |
| Last modified on | 2013/05/22 12:32:56 |
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Basic information
Public title
Transition of Anti-pertussis Antibodies and the Safety of Japanese Diphteria-acellular Pertussis-Tetanus Vaccine administered in reduced doses among Adults
Acronym
Effect and the Safety of DTP vaccine administered in reduced doses among Adults
Scientific Title
Transition of Anti-pertussis Antibodies and the Safety of Japanese Diphteria-acellular Pertussis-Tetanus Vaccine administered in reduced doses among Adults
Scientific Title:Acronym
Effect and the Safety of DTP vaccine administered in reduced doses among Adults
Region
| Japan |
Condition
Condition
pertussis
Classification by specialty
| Infectious disease | Pediatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the transition of anti-pertussis antibodies and the safety of Japanese Diphteria-acellular Pertussis-Tetanus Vaccine administered in reduced doses among healthy adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
increased anti-pertussis antibodies titer after vaccination
Key secondary outcomes
relative frequency of side effects after vaccination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
A term is four weeks
Amout of vaccination is 0.2mL
A number of times is one time
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Docters, Nurses, Nursery nurse
Key exclusion criteria
The person who is infected a malignancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mio Kohno |
Organization
National Hospital Organization Saitama National Hospital
Division name
Department of Pediatrics
Zip code
Address
2-1, Suwa, Wako City, Saitama, Japan
TEL
048-462-1101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mio Kohno |
Organization
National Hospital Organization Saitama National Hospital
Division name
Department of Pediatrics
Zip code
Address
2-1, Suwa, Wako City, Saitama, Japan
TEL
048-462-1101
Homepage URL
Sponsor or person
Institute
National Hospital Organization Saitama National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Saitama National Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
独立行政法人国立病院機構埼玉病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 22 | Day |
Last modified on
| 2013 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012612
