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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008025
Receipt No. R000009443
Scientific Title Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU
Date of disclosure of the study information 2012/05/24
Last modified on 2014/11/28

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Basic information
Public title Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU
Acronym Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU
Scientific Title Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU
Scientific Title:Acronym Safety Research of administration of DTP, PCV7, Hib Vaccines to Infants at NICU
Region
Japan

Condition
Condition Adverse events of vaccines
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of simultaneous administration of multiple vaccines to infants at NICU according to chronological age.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency and type of adverse events following vaccines administration
Key secondary outcomes Factors associated with adverse events following vaccines administration

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
8 weeks-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Infants at NICU or GCU
Body weight 1500g or over
Written consent is obtained
Key exclusion criteria Previous history of vaccinations
Acute illness such as acute infection, acute metabolic disorder, acute renal disorder, acute cardiac disorder, acute neurological disorder and acuter respiratory disorder
13 trisomy and 18 trisomy including mosaic
Patients who were considered as inappropriate to participate in this study by responsible physicians
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuho Horikoshi
Organization Tokyo Metropolitan Children's Medical Center
Division name Infectious Diseases
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Email yuho_horikoshi@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Morikawa
Organization Tokyo Metropolitan Children's Medical Center
Division name Clinical Research
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Homepage URL
Email yoshihiko_morikawa@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization None
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
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 東京都立小児総合医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 24 Day

Related information
URL releasing protocol https://docs.google.com/file/d/0B1ao6fLO1AA5dnVhWmhwZjVOeDA/edit
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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2014 Year 05 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information New onset of symptoms, physical findings and diseases after vaccinations
Worsening of symptoms, physical findings and diseases after vaccinations

Management information
Registered date
2012 Year 05 Month 24 Day
Last modified on
2014 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009443

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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