UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016961 |
|---|---|
| Receipt number | R000019687 |
| Scientific Title | Surveillance for adverse reactions by vaccination in health infants: 2nd Prospective Study ( in Japan ) |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2015/03/29 19:10:42 |
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Basic information
Public title
Surveillance for adverse reactions by vaccination in health infants:
2nd Prospective Study ( in Japan )
Acronym
2nd safety surveillance for vaccination
Scientific Title
Surveillance for adverse reactions by vaccination in health infants:
2nd Prospective Study ( in Japan )
Scientific Title:Acronym
2nd safety surveillance for vaccination
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the safety of single vaccination and simultaneous vaccination with multiple vaccines (DTP-IPV, PCV13 etc.).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reactions occur within 14 days after vaccination (general reaction and local reaction)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 2 | months-old | <= |
Age-upper limit
| 60 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Age: over 2 month and under 5 years of age
Subjects whose parents require single vaccination or simultaneous vaccination,
Each vaccine are determined to be appropriate on pre examination by physicians
Key exclusion criteria
Age: under 2 and over 5 years of age
Subjects whose parents do not require vaccination to their children
Vaccination is determined to be inappropriate on pre-examination by physicians
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tahara |
Organization
Tahara clinic
Division name
Director
Zip code
Address
47 Ushirogawara, Yamaguchi city, Yamaguchi prefecture
TEL
083-923-3415
drtak@juno.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashiro Tahara |
Organization
Tahara clinic
Division name
Director
Zip code
Address
47 Ushirogawara, Yamaguchi city, Yamaguchi prefecture
TEL
083-923-3415
Homepage URL
http://www.taharaclinic.com/
drtak@juno.ocn.ne.jp
Sponsor or person
Institute
The society of ambulatory and general pediatrics in Japan
Institute
Department
Personal name
Funding Source
Organization
The society of ambulatory and general pediatrics in Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
To analyze adverse reactions occur within 14 days after vaccination (general reaction and local reaction) to compare between single injection and simultaneous injection.
Management information
Registered date
| 2015 | Year | 03 | Month | 29 | Day |
Last modified on
| 2015 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019687
