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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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