UMIN-CTR Clinical Trial

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
Last 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
Email	yoshihiko_morikawa@tmhp.jp

Public contact
1st 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
Email	yoshihiko_morikwa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026271