UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect and safety of Diphteria-Pertussis-Tetanus vaccine among healthcare workers
Title of the study (Brief title)	Effect and safety of DTaP among healthcare workers
Region	Japan

Condition
Condition	Pertussis
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pertussis is epidemic throughout the world in young adults. Tdap has been used in many countries and is proved to be effective for elevation levels of antibody to Pertussis. Since it takes so many years to obtain the license of new vaccine in Japan, we have no other option but to use DTaP alternatively. There are few studies which examined the usefulness and effectiveness of DTaP administered to adults. Moreover no study had ever discussed the duration of effectiveness. In this study we monitored Pertussis titers of healthcare workers who provide medical care to children by examined antibodies against PT, FHA, Fim2, Fim3, catACT and cFHA.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We measure antibodies against PT, FHA, Fim2, Fim3, catACT and cFHA using enzyme-linked immunosorbent assay before vaccination, one month and one year after vaccination.
Key secondary outcomes	We carry out a questionnaire survey to examine the safety of vaccination within seven days after administration about the presence of fever, headache, malaise, pain, redness, swelling and sensations of burning.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	We examine the study from January 1st, 2014 to January 31th, 2015. We measure antibodies against Pertussis antigen in the eligible person who obtained our consent, thereafter we vaccinate with DTaP which are reduced from 0.5mL to 0.2mL.
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	- Healthcare worker who work in hospital ward and outpatient department at Children's Medical Center and Perinatal Center, Yokohama City University Medical Center. - Eligible person who obtained our consent. - Age over the 20 years old and under the 65 years old.
Key exclusion criteria	- Healthcare worker who had a history of serious side effect from vaccination.
Target sample size	150

Research contact person
Name of lead principal investigator	Hiroyuki Shimizu
Organization	Yokohama City University Medical Center
Division name	Children's Medical Center
Address	4-57, Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, Japana
TEL	045-261-5656
Email	hiroyukiowl@hotmail.co.jp

Public contact
Name of contact person	Hiroyuki Shimizu
Organization	Yokohama City University Medical Center
Division name	Children's Medical Center
Address	4-57, Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, Japana
TEL	045-261-5656
Homepage URL
Email	hiroyukiowl@hotmail.co.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	Yokohama City University Medical Center Children's Medical Center Perinatal Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kitasato Institute for Life Sciences
Name of secondary funｄer(s)

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	横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 16 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 02 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 16 Day
Last modified on	2017 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024747