UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047780 |
|---|---|
| Receipt number | R000054468 |
| Scientific Title | Injection Site Local Reactions to Acellular Pertussis Vaccine in children |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/17 12:27:48 |
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Basic information
Public title
Injection Site Local Reactions to Acellular Pertussis Vaccine in children
Acronym
DTaP study in Japan
Scientific Title
Injection Site Local Reactions to Acellular Pertussis Vaccine in children
Scientific Title:Acronym
DTaP study in Japan
Region
| Japan |
Condition
Condition
Pertussis, Diphtheria, Tetanus
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the relationship between local reactions to diphtheria, tetanus toxoids and acellular pertussis (DTaP) vaccine and the injection site.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local reactions by each injection site during 14 days after DTaP vaccination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
DTaP vaccination to the upper arm.
Interventions/Control_2
DTaP vaccination to the thigh.
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
| 4 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
4-6 year-old children,
11-13 year-old adolescents,
Any age of adult health care workers
Key exclusion criteria
1) Those who have been vaccinated with DTaP, DTaP-IPV, DT, Tdap within 6 months
2) Those who have received a total of 5 or more doses of DTaP, DTaP-IPV, DT, and Tdap vaccines
3) Contraindicated cases to DTaP vaccine
4) Pregnant women
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Katsuta |
Organization
St. Marianna University School of Medicine
Division name
Department of pediatrics
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81449778111
katsuta-7-@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Katsuta |
Organization
St. Marianna University School of Medicine
Division name
Department of pediatrics
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
+81449778111
Homepage URL
katsuta-7-@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine,
Department of pediatrics
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel
+81449778111
k-sienbu.mail@marianna-u.ac.jp
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
| 2022 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054468
