UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022793 |
|---|---|
| Receipt number | R000026271 |
| Scientific Title | A trial for evaluation of effectiveness and safety for dose reduction DTP-IPV vaccination in adult |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2019/04/01 14:42:10 |
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Basic information
Public title
A trial for evaluation of effectiveness and safety for dose reduction DTP-IPV vaccination in adult
Acronym
dose reduction vaccination of DTP-IPV in adult
Scientific Title
A trial for evaluation of effectiveness and safety for dose reduction DTP-IPV vaccination in adult
Scientific Title:Acronym
dose reduction vaccination of DTP-IPV in adult
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Medicine in general | Infectious disease | Pediatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of pertussis antibody titer and safety of DTP-IPV titer by reduced dose of DTP-IPV vaccine in adult
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
pertussis antibody titer after vaccination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
single dose vaccination: DTP-IPV vaccine 0.25 ml
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. work in the cooperating institute
2.Informed consent to participate in the study was given
Key exclusion criteria
1. inoculated pertussis vaccine for adulthood
2. past history for pertussis infection
3. chronic kidney disease
4. immunodeficiency
5. using immunosuppresant or oral steroid
6. past history for anaphyraxis by vaccines
7. Judged inappropriate for this study by the physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Morikawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8561, Japan
TEL
042-300-5111
yoshihiko_morikawa@tmhp.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Morikawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8561, Japan
TEL
042-300-5111
Homepage URL
yoshihiko_morikwa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Project Research fund
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The echical comittee of Tokyo Metroplitan Children's Medical Center
Address
2-8-29, Musashidai, Fuchu, Tokyo
Tel
042-300-5111
sn_rinri@tmhp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H27b-177
Org. issuing International ID_1
Tokyo Metropolitan Children's Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
