作者
Javier Diez-Domingo, Thomas Weinke, Juan Garcia de Lomas, Claudius U Meyer, Isabelle Bertrand, Cécile Eymin, Stéphane Thomas, Christine Sadorge
发表日期
2015/2/4
期刊
Vaccine
卷号
33
期号
6
页码范围
789-795
出版商
Elsevier
简介
Zostavax® is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was administrated by the subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines by the intramuscular (IM) route. This was an open-label, randomised trial conducted in 354 subjects aged ≥50 years. The primary objectives were to demonstrate that IM administration is both non-inferior to SC administration in terms of 4-week post-vaccination geometric mean titres (GMTs), and elicits an acceptable geometric mean fold-rise (GMFR) of antibody titres measured by glycoprotein enzyme-linked immunosorbent assay. Pre-specified non-inferiority was set as the lower bound of the 95% confidence interval (CI) of the GMT ratio (IM/SC) being …
引用总数
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