UMIN-CTR Clinical Trial

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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