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Prior to marketing of pandemic influenza vaccines, the only safety data were those from clinical trials. The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients’ population. Out of a sample of 507 vaccinated...
Our study reviews the spontaneous reports of adverse events following immunisation submitted to the Danish Medicines Agency during the 2009–2010 influenza A/H1N1v season. During the study period (4 November 2009–31 March 2010), 607 reports comprising 1885 adverse events were reported among 339,507 influenza A/H1N1v vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). The majority of...
The occurrence of pandemic H1N1 influenza in 2009 led health authorities to promptly start massive vaccination campaigns. Due to the need of shortening time for development and approval, the pandemic vaccine was prepared by mock-up strategy, and limited safety data were available upon starting vaccine administration.To determine the frequencies and clinical features of adverse events (AEs) observed...
The aim of this study was to compare the immunogenicity and reactogenicity of a lower dose diphtheria, tetanus and pertussis vaccine (dTpa) with the recommended vaccine (DTPa) given as a fifth dose to 4–6-year old children who previously experienced an extensive injection site reaction (ISR).Children aged 4–6 years who had experienced an extensive ISR following a 4th dose of DTPa were recruited and...
In 2005, an acellular pertussis-containing DTP-IPV-Hib vaccine for infants replaced the whole-cell combination vaccine in the National Immunisation Programme of the Netherlands. From 2008 onwards, an increase in local reactions to boosters was seen in an enhanced passive reporting system of adverse events following immunisation.A cross-sectional study was conducted to assess the difference in tolerability...
There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal ® , comparing data...
In June 2009, WHO declared the maximum phase alert against H1N1 pandemic flu. Health care workers (HCWs) are considered a strategic target for prevention of the occurrence of H1N1 influenza since they had the greatest risk of acquiring infection. The objectives of our study were (1) identifying the uptake of influenza A(H1N1) 2009 monovalent vaccine by primary health care workers in the southern part...
The purpose of the study was to assess post-vaccination immune response and occurrence of adverse events in the group of prematurely born infants. The study included 40 pre-term infants. Each child was vaccined four times (2, 4, 6 and 16 months) with the heptavalent conjugated pneumococcal vaccine (PCV7). Assessing of the level of antibodies was performed before vaccination, 4 weeks after primary...
To assess the reactogenicity of two 2010 trivalent inactivated influenza vaccine (TIV) formulations among adults, including the formulation associated with febrile convulsions among children in Australia.We retrospectively interviewed persons aged ≥18 years who received TIV between 11 March and 24 April 2010 at a large general practice in Perth. All 160 persons who received Influvac® (Solvay) and...
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