Unique ID issued by UMIN | UMIN000009888 |
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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 |
A study about immunogenicity and safety of an additional varicella vaccination
A study about an additional varicella vaccination
A study about immunogenicity and safety of an additional varicella vaccination
A study about an additional varicella vaccination
Japan |
varicella
Pediatrics | Child |
Others
NO
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.
Safety,Efficacy
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.
Observational
1 | years-old | <= |
15 | years-old | > |
Male and Female
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
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.
30
1st name | |
Middle name | |
Last name | Takao Ozaki |
Konan Kosei Hospital
Department of Pediatrics
137 Ohmatsubara Takaya-cho, Konan, Aichi
0587-51-3333
1st name | |
Middle name | |
Last name | Naoko Nishimura |
Konan Kosei Hospital
Department of Pediatrics
137 Ohmatsubara Takaya-cho, Konan, Aichi
0587-51-3333
Konan Kosei Hospital
none
Self funding
NO
江南厚生病院(愛知県)
2013 | Year | 01 | Month | 28 | Day |
Published
We presented the results at the 16th annual meeting of the Japanese Society for Vaccinology on November 17, 2012
Completed
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 02 | Month | 03 | Day |
prospective study
2013 | Year | 01 | Month | 28 | Day |
2013 | Year | 01 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011585
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