UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of anesthesia on the antibody response of vaccination
Title of the study (Brief title)	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	Oi Yumiko
Organization	Mie National Hospital
Division name	Pediatrics
Address	Oosatokubota cho 357,Tsu city, Mie Pref.
TEL	09047998774
Email	yu20972007@yahoo.co.jp

Public contact
Name of contact person	Oi Yumiko
Organization	Mie National Hospital
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012824