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    ABSTRACT: Despite the advent of the Papanicolaou smear test almost 50 years ago, cervical cancer remains the second most common malignant disease in women and the leading cause of cancer death in developing countries. Thus the two prophylactic human papillomavirus (HPV) vaccines currently available have been greeted with enthusiasm internationally, as an emerging primary prevention strategy against cervical cancer. Prior to licensure the vaccines were trialed in over 60,000 women and assessed as safe, within the statistical constraints of the trials to detect very rare events. Post-licensure surveillance is underway as vaccination programs are undertaken. We reviewed published post-licensure surveillance data, as at January 2009, and concur with international advisory bodies that both HPV vaccines are safe, effective and of great importance for women's health. Ongoing monitoring is required to maintain confidence in the safety of the vaccines.
    No preview · Article · Sep 2009 · Vaccine
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    ABSTRACT: When H1N1v vaccines become widely available, most elderly subjects will have already received their seasonal influenza vaccination. Adults seeking H1N1v vaccination may be offered seasonal vaccine as well. We investigated prior seasonal vaccination in adult and elderly subjects, and concomitant vaccination with seasonal vaccine in adults, on the tolerability and immunogenicity of the Novartis MF59-adjuvanted H1N1v vaccine, Focetria. A total of 264 adult (four groups) and 154 elderly (three groups) subjects were enrolled. The licensure study cohorts for plain (Agrippal) and MF59-adjuvanted (Fluad) 2009-2010 seasonal vaccines were invited to receive Focetria 3 months later, with seasonal vaccine-naïve controls, and adults who received Focteria and seasonal vaccine concomitantly. Immunogenicity of all vaccines was assessed by haemagglutination inhibition on Days 1 and 22, safety and reactogenicity were monitored using patient diaries. All adult and elderly groups met all the European CHMP licensing criteria for H1N1v, as did adults receiving concomitant seasonal vaccine for the three seasonal strains. Vaccines were generally well tolerated, causing no SAEs, and profiles typical of MF59-adjuvanted vaccines. Reactions were mainly mild or moderate and transient, and unaffected by prior or concomitant seasonal vaccination except for elderly subjects previously given MF59-adjuvanted seasonal vaccine, whose reaction rates to Focetria were about half those seen in groups receiving their first MF59 vaccine. One dose of MF59-adjuvanted H1N1v vaccine met the licensure criteria for adult and elderly subjects 3 months after seasonal vaccination, or concomitantly with seasonal vaccine in adults, without impacting the tolerability or immunogenicity of either vaccine, thus facilitating mass influenza immunisation campaigns.
    Full-text · Article · Mar 2010 · International Journal of Clinical Practice
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    ABSTRACT: The Brighton Collaboration (BC) was established in 2000 with the aim of developing globally accepted standardized case definitions for adverse events following immunizations (AEFI) as well as guidelines for the collection, analysis and presentation of surveillance data. Some of the BC case definitions are complex and this may limit their application for use in post-marketing vaccine surveillance. Barriers to the application of the BC case definitions include an incomplete description of an adverse event and inconsistencies in reporter use of adverse event terms. We have taken the BC case definition for anaphylaxis and developed a clinical checklist and glossary of terms used in the case definition. It is anticipated that these resources can be used at a community level by AEFI reporters. If used, these resources could improve the quality of adverse event reports which would facilitate the application of the BC case definition at a regional and/or national level.
    No preview · Article · Apr 2010 · Vaccine
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