UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007164 |
|---|---|
| Receipt number | R000008443 |
| Scientific Title | Heisei 23, Health and labour sciences research grants (the H1N1 flu virus etc. emerging and reemerging infectious diseases research project)[Research on pediatric infectious diseases becoming a serious problem to adult infection] (H21, emerging, general -011) Safety of Vaccine : comparison of single shot and simultaneous shots |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2013/07/31 07:30:50 |
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Basic information
Public title
Heisei 23, Health and labour sciences research grants (the H1N1 flu virus etc. emerging and reemerging infectious diseases research project)[Research on pediatric infectious diseases becoming a serious problem to adult infection]
(H21, emerging, general -011) Safety of Vaccine : comparison of single shot and simultaneous shots
Acronym
Safety of Vaccine : comparison of single shot and simultaneous shots
Scientific Title
Heisei 23, Health and labour sciences research grants (the H1N1 flu virus etc. emerging and reemerging infectious diseases research project)[Research on pediatric infectious diseases becoming a serious problem to adult infection]
(H21, emerging, general -011) Safety of Vaccine : comparison of single shot and simultaneous shots
Scientific Title:Acronym
Safety of Vaccine : comparison of single shot and simultaneous shots
Region
| Japan |
Condition
Condition
Healthy infant
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 (PCV7, Hib, DTP etc.).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Side effects occur within 14 days after vaccination (general reaction and local reaction)
Key secondary outcomes
Other adverse events
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
| 0 | months-old | <= |
Age-upper limit
| 60 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1]Age: over 2 month and under 5 years of age
2]Subjects whose parents require single vaccination or simultaneous vaccination,
3]Each vaccine are determined to be appropriate on pre examination by physicians
Key exclusion criteria
1]Age: under 2 and over 5 years of age
2]Subjects whose parents do not require vaccination to their children
3]Vaccination is determined to be inappropriate on pre examination by physicians
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Okada |
Organization
National Hospital Organization Fukuoka National Hospital
Division name
Medical Division
Zip code
Address
4-39-1 Yakatabaru, Minami-ku , Fukuoka 811-1394 JAPAN
TEL
092-565-5534
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Okada |
Organization
National Hospital Organization Fukuoka National Hospital
Division name
Medical Division
Zip code
Address
4-39-1 Yakatabaru, Minami-ku , Fukuoka 811-1394 JAPAN
TEL
+81-92-565-5534
Homepage URL
okadak@mfukuoka2.hosp.go.jp
Sponsor or person
Institute
Kenji Okada
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama City University Medical Center
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
かやば小児科医院（宮城県）、かわむらこどもクリニック（宮城県）、崎山小児科（東京都）、みやた小児科（東京都）、横浜市立大学市民総合医療センター小児総合医療センター（神奈川県）、ふじおか小児科（大阪府）、たはらクリニック（山口県）、たにむら小児科（山口県）、よしだ小児科医院（福岡県）、こどもクリニックもりた（福岡県）、げんきこどもクリニック（静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
Bacterial meningitis is one of the most serious infectious diseases in children. It is seen as a thread because of leaving after effects and having an influence on life prognosis with a difficulty of early diagnosis. It is reported that in US and Europe, the vaccine for Haemophilus influenza type B (HIB), main pathogen of bacterial meningitis, was introduced and 7-valent pneumococcal conjugate vaccine (PCV7) became the regular vaccine schedule that significantly reduced bacterial meningitis. In Japan that the effective provision to preventable bacterial meningitis by vaccination is to give PCV7 and Hib concomitantly, which were released in 2010 and 2008. Although in other countries, simultaneous vaccination that gives multiple vaccines at one visit is common, in Japan, single vaccination is basically permitted except for cases physicians admit simultaneous vaccination. In order to having necessary vaccine effectively without frequent visits to physicians, simultaneous vaccination, PCV7 and Hib whose timing of vaccination are nearly the same, and DTP of regular vaccination schedule, is likely to increase. In the meantime, there are some physicians and parents concerning about an increasing possibility of side effects caused by simultaneous vaccination. Therefore, at this time, we are planning on investigating the safety of single vaccination and simultaneous vaccination. This research would give expectations for the safety of simultaneous vaccination to infants in Japan and will be expected to increase selection of vaccination methods that results in availability of efficient vaccination to children, their parents, and medical experts without frequent visits to a clinic.
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2013 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008443
| 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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