UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020168
Receipt number R000023301
Scientific Title Evaluation of immunogenicity in children 7 years after Varicella vaccination
Date of disclosure of the study information 2015/12/11
Last modified on 2019/03/25 15:46:30

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Basic information

Public title

Evaluation of immunogenicity in children 7 years after Varicella vaccination

Acronym

An immunogenicity study in children after Varicella vaccination

Scientific Title

Evaluation of immunogenicity in children 7 years after Varicella vaccination

Scientific Title:Acronym

An immunogenicity study in children after Varicella vaccination

Region

Japan


Condition

Condition

Healthy children

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evalation of immunogenicity in children 7 years after Varicella vaccination

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Antibody against Varicella Zoster Virus

Key secondary outcomes



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

6 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

vaccinated children

Key exclusion criteria

children who was not applicable to be immunized

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Atsuko
Middle name
Last name Hata

Organization

Kitano hospital, The Tazuke Kofukai Medical Research Institute

Division name

Department of Pediatrics

Zip code

5308480

Address

2-4-20 Ohgimachi Kitaku Osaka 530-8480

TEL

06-6312-8824

Email

ahata@kitano-hp.or.jp


Public contact

Name of contact person

1st name Satomi
Middle name
Last name Taku

Organization

Kitano hospital, The Tazuke Kofukai Medical Research Institute

Division name

Clinical Research Institute

Zip code

5308480

Address

2-4-20 Ohgimachi Kitaku Osaka 530-8480

TEL

06-6312-1221

Homepage URL


Email

rinshou@kitano-hp.or.jp


Sponsor or person

Institute

Kitano hospital, The Tazuke Kofukai Medical Research Institute

Institute

Department

Personal name



Funding Source

Organization

The Tazuke Kofukai foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitano hospital, The Tazuke Kofukai Medical Research Institute Ethics Committee

Address

2-4-20 Ohgimachi Kitaku Osaka 530-8480Japan

Tel

06-6312-1221

Email

rinshou@kitano-hp.or.jp


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



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 11 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

11

Results

The mean gpELISA against VZV were 3.34+-0.45 in 7 children who had received 1 dose of varicella vaccine and these were 3.39+-1.02 in 4 children who had 2 doses of varicella vaccine because of primary vaccine failure (p = .09).

Results date posted

2019 Year 03 Month 25 Day

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

Completed

Date of protocol fixation

2013 Year 12 Month 20 Day

Date of IRB

2013 Year 12 Month 26 Day

Anticipated trial start date

2013 Year 12 Month 26 Day

Last follow-up date

2019 Year 03 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study Design: case-control study
Recruitment methods: The children that varicella vaccination at the nursery in Osaka city between March and June in 2007 were asked to participate this study with sealed letter.
Investigation: We investigated the subject's development of varicella. The observation period was after vaccination in 2007 up to May 2014.


Management information

Registered date

2015 Year 12 Month 11 Day

Last modified on

2019 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023301


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name