Monthly Update: Anti-infectives: VAQTA: Merck's hepatitis A vaccine, purified, inactivated
| Autor: | June R Manns, Barbara J. Kuter, Leora Brown, David R. Nalin, William Hurni, Jacqueline Gress |
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| Rok vydání: | 1995 |
| Předmět: | |
| Zdroj: | Expert Opinion on Investigational Drugs. 4:1313-1319 |
| ISSN: | 1744-7658 1354-3784 |
| Popis: | The safety/tolerability profile, immunogenicity and protective efficacy of VAQTA, Merck's hepatitis A vaccine, purified, inactivated, are based on studies of 18,239 vaccinees; 12,000 2–17 years and 6239 18 years and older. To date, no vaccinee has had any serious vaccine-related adverse experience. In placebo-controlled studies, the local and systemic adverse experience profile has been indistinguishable from that of placebo alum diluent. The goal of ≥ 95% seropositivity was achieved within 4 weeks after one im dose of 25 units (2–17 year olds, 1 U ≥1 ng of purified viral protein; 18 –76 year olds, 50 U). Anamnestic responses to a booster given at 6,12 or 18 months revealed that the priming dose conferred immune memory in > 99% of vaccinees, regardless of pre-booster antibody level.Protective efficacy of 100% starting at least as early as day 21 after a single dose was proven in a randomised, double-blinded field trial among 2–16 year olds in Monroe, NY. Although prior to the vaccine trial cases occurred ... |
| Databáze: | OpenAIRE |
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