UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008025 |
|---|---|
| Receipt number | 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 09:25:53 |
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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
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
yoshihiko_morikawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009443
