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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016740 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | healthy adult | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. work in the cooperating institute
2.Informed consent to participate in the study was given |
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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 |
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Target sample size | 130 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Tokyo Metropolitan Children's Medical Center |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 | |
Registered date | File name |