A comparison of safety, tolerability and immunogenicity of Oka/Merck varicella vaccine and VARILRIXTM in healthy children

被引:44
作者
Lau, YL
Vessey, SJR
Chan, ISF
Lee, TL
Huang, LM
Lee, CY
Lin, TY
Lee, BW
Kwan, K
Kasim, SM
Chan, CY
Kaplan, KM
Distefano, DJ
Harmon, AL
Golie, A
Hartzel, J
Xu, J
Li, S
Matthews, H
Sadoff, JC
Shaw, A
机构
[1] Merck & Co Inc, West Point, PA 19486 USA
[2] Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China
[3] Natl Taiwan Univ Hosp, Taipei, Taiwan
[4] Chung Gung Childrens Hosp, Taipei, Taiwan
[5] Natl Univ Singapore Hosp, Singapore 117548, Singapore
[6] Klin Kanak Kanak Kwan, Selangor, Malaysia
[7] Inst Pediat, Kuala Lumpur, Malaysia
关键词
varicella zoster virus; immunogenicity; varicella vaccination;
D O I
10.1016/S0264-410X(02)00245-1
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
This study compared safety, tolerability, and immunogenicity of the Oka/Merck varicella vaccine and VARILRIX(TM) [Oka-RIT strain SmithKline Beecham Biologicals] in healthy children 12-24 months of age. Subjects were randomized in this double blind study to receive either a single dose of Oka/Merck varicella vaccine, (similar to50,000 plaque forming units (PFU), Group A or similar to16,000 PFU, Group B) or 1 dose of VARILRIX(TM), (similar to40,000 PFU/dose, Group C). Safety profiles in each treatment group were similar. The proportions of subjects achieving a 6-week postvaccination titer greater than or equal to5 gpELISA units in Groups A, B or C were 97.1, 95.2 and 85.6%, respectively. (C) 2002 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:2942 / 2949
页数:8
相关论文
共 22 条
[1]  
ANDRE FE, 1985, POSTGRAD MED J, V61, P113
[2]   CELL-MEDIATED-IMMUNITY TO VARICELLA-ZOSTER VIRUS [J].
ARVIN, AM .
JOURNAL OF INFECTIOUS DISEASES, 1992, 166 :S35-S41
[3]  
CHAN ISF, IN PRESS STAT MED
[4]  
DHONDT E, 1985, POSTGRAD MED J, V61, P53
[5]  
JUST M, 1985, POSTGRAD MED J, V61, P129
[6]   Varicella vaccine in non-immune household contacts of children with cancer or leukaemia [J].
Kappagoda, C ;
Shaw, PJ ;
Burgess, MA ;
Botham, SJ ;
Cramer, LD .
JOURNAL OF PAEDIATRICS AND CHILD HEALTH, 1999, 35 (04) :341-345
[7]   Comparison of gpELISA and neutralizing antibody responses to Oka/Merck live varicella vaccine (Varivax(R)) in children and adults [J].
Krah, DL ;
Cho, IS ;
Schofield, T ;
Ellis, RW .
VACCINE, 1997, 15 (01) :61-64
[8]   Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection [J].
Li, S ;
Chan, ISF ;
Matthews, H ;
Heyse, JF ;
Chan, CY ;
Kuter, BJ ;
Kaplan, KM ;
Vessey, SJR ;
Sadoff, JC .
PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2002, 21 (04) :337-342
[9]  
*MERCK CO INC, 2000, M M R I PACK INS
[10]   COMPARATIVE-ANALYSIS OF 2 RATES [J].
MIETTINEN, O ;
NURMINEN, M .
STATISTICS IN MEDICINE, 1985, 4 (02) :213-226