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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010981
Receipt No. 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

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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
Email 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
Email yu20972007@yahoo.co.jp

Sponsor
Institute Mie National Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012824

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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