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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010779
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Hospital Organization Saitama National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012612

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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