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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007164
Receipt No. 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

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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
Email

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
Email okadak@mfukuoka2.hosp.go.jp

Sponsor
Institute Kenji Okada
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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