To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Liquid Rotavirus Vaccine Not Inferior to Lypholised Version: Presented at ESPID URL: http://www.pslgroup.com/dg/221516.htm Doctor's Guide May 14, 2008
By Neil Osterweil GRAZ, Austria -- May 14, 2008 -- A liquid formulation of an oral, live, attenuated human rotavirus vaccine has been shown to be noninferior to the lypholised formulation, reported investigators here at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The liquid form of the vaccine was shown to be comparable to the lypholised version in terms of both anti-rotavirus immunoglobulin-A (IgA) seroconversion rates and geometric mean concentrations (GMCs), according to Timo Vesikari, MD, Professor, University of Tampere Medical School in Tampere, Finland, and colleagues. Unlike the lypholised version, the liquid formulation does not require constitution, and may allow more flexibility in the vaccine supply, the investigators reported in a poster session. The 2 formulations were tested head-to-head in a double-blind, randomised, phase 3 trial involving 1,200 healthy Finnish infants aged 10 to 17 weeks. The children were enrolled to receive 2 doses of the lypholised formulation or the liquid formulation on a 0- to 1-month schedule. The vaccine was given concomitantly with a 6-valent vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b. The authors assessed anti-rotavirus IgA seroconversion rates both before the first dose and 1 month after the second dose using a cut-off of 20 U/mL by enzyme-linked immunosorbent assay that also calculated corresponding GMCs. The researchers defined "noninferiority" at 1 month after the second dose as the upper limit of 2-sided asymptotic standardised 95% confidence interval (CI) of 10% for difference in seroconversion rate between the 2 formulations, and the upper limit of 2-sided 95% CI 2 for GMCs ratio. They also recorded solicited and unsolicited data from patients about symptoms. They found that the anti-rotavirus IgA seroconversion rate 1 month after the second dose was 88.6% (95% CI, 86.1-90.8) in the 746 children who received the liquid formulation, and 90.5% (95% CI, 86.2-93.8) among the 252 infants who received the lypholised vaccine. One month after the second dose, the anti-rotavirus IgA GMC was 374.7 U/mL (95% CI, 328.8-426.9) among the infants in the liquid vaccine group versus 331.8 U/mL (95% CI, 265.0-415.4) in the group given the lypholised formulation. The authors said the liquid formulation met the predefined criteria for noninferiority, and the reactogenicity of the 2 vaccine formulations were similar. "As rotavirus universal mass vaccination programs are implemented worldwide, a liquid formulation allows flexibility in supply," the authors commented. [Presentation title: Immunogenicity and Reactogenicity of Liquid Versus Lyophilized Formulation of Rotarix (Rix4414) Live-Attenuated Human Rotavirus Vaccine in Finland. ESPID abstract 134] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.