UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016740 |
|---|---|
| Receipt number | R000019427 |
| Scientific Title | Randomized controlled trial to evaluate the dose of DTP-IPV vaccine for adult |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2019/04/01 14:44:03 |
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Basic information
Public title
Randomized controlled trial to evaluate the dose of DTP-IPV vaccine for adult
Acronym
Randomized controlled study to evaluate the dose of DTP-IPV vaccine for adult
Scientific Title
Randomized controlled trial to evaluate the dose of DTP-IPV vaccine for adult
Scientific Title:Acronym
Randomized controlled study to evaluate the dose of DTP-IPV vaccine for 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 superiority of rising pertussis antibody titer by normal dose over reduced dose of DTP-IPV vaccine in adult
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
geometric mean of pertussis antibody titer after vaccination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
DTP-IPV vaccine 0.5 mL sc single dose
Interventions/Control_2
DTP-IPV vaccine 0.2 mL sc single dose
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
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuho Horikoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Infectious Diseases
Zip code
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
81-42-300-5111
yuho_horikoshi@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Morikawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Clinical Research Support Center
Zip code
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
Homepage URL
morikawa@2005.jukuin.keio.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Tama Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 25 | 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
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2015 | 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
| 2015 | Year | 03 | Month | 08 | 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=R000019427
| 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 |
