UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010981 |
|---|---|
| Receipt number | R000012824 |
| Scientific Title | Effects of anesthesia on the antibody response of vaccination |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2017/06/21 17:42:22 |
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Basic information
Public title
Effects of anesthesia on the antibody response of vaccination
Acronym
Effects of anesthesia on the antibody response of vaccination
Scientific Title
Effects of anesthesia on the antibody response of vaccination
Scientific Title:Acronym
Effects of anesthesia on the antibody response of vaccination
Region
| Japan |
Condition
Condition
Preschooler with no antibody of influenza
Classification by specialty
| Pediatrics | Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative vaccination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the antibody at 4 weeks after the preoperative vaccination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
for 3 years
Influenza vaccinations(1 week before surgery and at one month after surgery )
blood sampling at preoperative 1 week and postoperative day 1, 7 and 1 month
Interventions/Control_2
Control:twice influenza vaccinations
blood sampling before vaccination and at 1 month after vaccination
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
| 1 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children undergoing pediatric surgery
healthy children
Written consent is obtained
Key exclusion criteria
Previous history of vaccinations
Patients who were considered as inappropriate to participate in this study by responsible physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oi Yumiko |
Organization
Mie National Hospital
Division name
Pediatrics
Zip code
Address
Oosatokubota cho 357,Tsu city, Mie Pref.
TEL
09047998774
yu20972007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oi Yumiko |
Organization
Mie National Hospital
Division name
Anesthesiology
Zip code
Address
059-232-2531
TEL
0592322531
Homepage URL
yu20972007@yahoo.co.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Mie Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
国立病院機構三重病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012824
