UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020168
Receipt No. 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 (Ver. 7)

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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
Last 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
1st 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
Institute Kitano hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023301