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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009888
Receipt No. R000011585
Scientific Title A study about immunogenicity and safety of an additional varicella vaccination
Date of disclosure of the study information 2013/01/28
Last modified on 2013/01/28

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Basic information
Public title A study about immunogenicity and safety of an additional varicella vaccination
Acronym A study about an additional varicella vaccination
Scientific Title A study about immunogenicity and safety of an additional varicella vaccination
Scientific Title:Acronym A study about an additional varicella vaccination
Region
Japan

Condition
Condition varicella
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although varicella vaccine became available in 1987 in Japan, number of varicella cases does not decrease at all afterwards. It seems that at first raising varicella vaccination coverage rate by implementing the routine vaccination program is necessary to reduce number of varicella cases.
In U.S.A. varicella vaccine was licensed in 1995, and the number of cases decreased remarkably by universal vaccination of its single dose. However, increase of breakthrough varicella in a community in a high vaccination coverage rate came to be reported rather after 2000, and its single dose vaccination program was changed to two-dose program in 2006 for the purpose of reducing breakthrough varicella. The 2-dose vaccination program in 12-15 months and 4-6 years old is taken in USA and gives a sufficient result. In addition, in other countries such as Germany or Australia, the 2-dose vaccination program is implemented in various different schedules.
The Japan Pediatric Society recommended 2-dose varicella vaccination program in 12-15 months and 18-23 months in April, 2012, but a clinical trial about it was not done. Clinical studies for implementation of the 2-dose vaccination program are necessary in our country. Therefore, we performed this study to clarify immunogenicity and safety of an additional vaccination at 3-5 years after the initial vaccination similar with the 2-dose program of USA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) IAHA and gpELISA antibody positive rates and mean IAHA and gpELISA antibody titers before and 4-6 wks after an additional varicella vaccination.
2) Comparison of the mean antibody titers after an additional vaccination and that after initial vaccination.
3) Incidence of clinical reactions for 4 weeks after an additional varicella vaccination.
4) Comparison of the incidence of clinical reactions after an additional varicella vaccination and that after initial vaccination.
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
1 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria Healthy children with an agreement of a parent on this study , who received varicella vaccine at the pediatric outpatient clinic of Konan Kosei Hospital in Japan between two years from Apr 2006 to Mar 2008
Key exclusion criteria We exclude the subjects who had antibody to VZV before an initial varicella vaccination, the subjects who received an additional varicella vaccination because of lack of seroconversion, and the subjects who had a history of breakthrough varicella.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Ozaki
Organization Konan Kosei Hospital
Division name Department of Pediatrics
Zip code
Address 137 Ohmatsubara Takaya-cho, Konan, Aichi
TEL 0587-51-3333
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Nishimura
Organization Konan Kosei Hospital
Division name Department of Pediatrics
Zip code
Address 137 Ohmatsubara Takaya-cho, Konan, Aichi
TEL 0587-51-3333
Homepage URL
Email

Sponsor
Institute Konan Kosei Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 江南厚生病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We presented the results at the 16th annual meeting of the Japanese Society for Vaccinology on November 17, 2012
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 Completed
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2013 Year 01 Month 28 Day
Last modified on
2013 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011585

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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