UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021495 |
|---|---|
| Receipt number | R000024747 |
| Scientific Title | Effect and safety of Diphteria-Pertussis-Tetanus vaccine among healthcare workers |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2017/11/18 07:42:57 |
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Basic information
Public title
Effect and safety of Diphteria-Pertussis-Tetanus vaccine among healthcare workers
Acronym
Effect and safety of DTaP among healthcare workers
Scientific Title
Effect and safety of Diphteria-Pertussis-Tetanus vaccine among healthcare workers
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimizu |
Organization
Yokohama City University Medical Center
Division name
Children's Medical Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, Japana
TEL
045-261-5656
hiroyukiowl@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimizu |
Organization
Yokohama City University Medical Center
Division name
Children's Medical Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa, Japana
TEL
045-261-5656
Homepage URL
hiroyukiowl@hotmail.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024747
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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