UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009888
Receipt number 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 19:23:04

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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 or person

Institute

Konan Kosei Hospital

Institute

Department

Personal name



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

Value
https://center6.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