1. A comparison of safety, tolerability and immunogenicity of Oka/Merck varicella vaccine and VARILRIX in healthy children.
- Author
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Lau YL, Vessey SJ, Chan IS, 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, and Shaw A
- Subjects
- Antibodies, Viral blood, Chickenpox Vaccine immunology, Double-Blind Method, Drug Tolerance, Enzyme-Linked Immunosorbent Assay, Female, Herpesvirus 3, Human immunology, Humans, Infant, Male, Safety, Vaccines, Attenuated adverse effects, Vaccines, Attenuated immunology, Chickenpox Vaccine adverse effects
- Abstract
This study compared safety, tolerability, and immunogenicity of the Oka/Merck varicella vaccine and VARILRIX [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, (approximately 50,000 plaque forming units (PFU), Group A or approximately 16,000 PFU, Group B) or 1 dose of VARILRIX, (approximately 40,000 PFU/dose, Group C). Safety profiles in each treatment group were similar. The proportions of subjects achieving a 6-week postvaccination titer> or = 5 gpELISA units in Groups A, B or C were 97.1, 95.2 and 85.6%, respectively.
- Published
- 2002
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