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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

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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
Email 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
Email 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
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

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
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


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