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Caron F.,University of Rouen | Du Chatelet I.P.,Institute of Veille Sanitaire | Leroy J.-P.,University of Rouen | Ruckly C.,Institute Pasteur Paris | And 14 more authors.
The Lancet Infectious Diseases | Year: 2011

Background: Outer-membrane-vesicle vaccines for meningococcal B outbreaks are complex and time consuming to develop. We studied the use of already available vaccine to control an outbreak caused by a genetically close strain. Methods: From 2006 to 2009, all individuals younger than 20 years living in the region of Normandy, France, in which an outbreak caused by a B:14:P1.7,16 strain occurred, were eligible to receive MenBvac, a Norwegian vaccine designed 20 years earlier against a strain sharing the same serosubtype (B:15:P1.7,16). The immunogenicity (in a randomly selected cohort of 400 children aged 1-5 years), safety, and epidemiological effect of the vaccination were assessed. Findings: 26 014 individuals were eligible to receive the vaccine. Shortage of vaccine production prompted start of the campaign in the highest incidence groups (1-5 years). 16 709 (64%) received a complete vaccination schedule of whom 13 589 (81%) received a 2+1 dose schedule (week 0, week 6, and month 8). At 6 weeks after the third dose, of 235 vaccinees for whom samples were available, 206 (88%) had a seroresponse, and 108 (56 %) of 193 had a seroresponse at 15 months. These results were similar to those described for tailor-made vaccines and their homologous strain. Only previously described adverse effects occurred. The incidence of B:14:P1.7,16 cases decreased significantly in the vaccine targeted population after the primary vaccination period (from 31·6 per 100 000 to 5·9 per 100 000; p=0·001). Interpretation: The ready-to-wear approach is reliable if epidemic and vaccine strains are genetically close. Other meningococcal B clonal outbreaks might benefit from this strategy; and previously described outer-membrane-vesicle vaccines can be effective against various strains. Funding: French Ministry of Health. © 2011 Elsevier Ltd. Source

Thiolet J.M.,Institute of Veille Sanitaire | Jourdan-Da Silva N.,Institute of Veille Sanitaire | Reggiani A.,Agence Francaise de Securite Sanitaire des Produits de Sante | De Valk H.,Institute of Veille Sanitaire | And 2 more authors.
Clinical Microbiology and Infection | Year: 2011

To investigate an increased incidence of human cultures growing Salmonella enterica ssp. diarizonae serotype 61:k:1,5,7 in France in 2008, we reviewed medical records of case patients and identified the material used during invasive procedures and for bacterial culture. Trace-back investigations incriminated culture media containing contaminated sheep blood agar. © 2010 The Authors. Clinical Microbiology and Infection © 2010 European Society of Clinical Microbiology and Infectious Diseases. Source

Auriche P.,Agence Francaise de Securite Sanitaire des Produits de Sante
British Journal of Clinical Pharmacology | Year: 2013

Aims: The risk of hypoglycaemia with tramadol (TRM) is not well described. Our aim was to analyze spontaneous reports of hypoglycaemia registered in the French Pharmacovigilance database and to compare these data with two other step-2 analgesic drugs. Methods: Cases of hypoglycaemia associated with TRM, dextropropoxyphene (DXP) and codeine (COD) recorded between 1997 and November 2010 in the French pharmacovigilance database were compared. Results: Seventy-two cases of hypoglycaemia associated with DXP and 43 with TRM were retained for evaluation (the single case reported with COD was not further considered). Most patients were elderly people with no significant difference in age between DXP- and TRM-treated patients (71.2 ± 21 vs. 69.4 ± 22.5 years). Hypoglycaemia occurred after a median of 4 and 5 days with DXP and TRM treatment, respectively. The mean lowest serum glucose concentration was 2.1 ± 0.9mmoll-1 in the DXP group compared with 2.5 ± 1mmoll-1 in the TRM group (P = 0.072). At least, one risk factor of hypoglycaemia was found in most patients, with no significant difference between groups (58.3% in the DXP group and 58.1% in the TRM group). In particular, 31.9% patients from the DXP group had diabetes compared with 41.8 % from the TRM group (P = 0.28) and 18% of DXP patients had renal insufficiency compared with 16.3% of TRM patients (P = 0.8). Conclusions: Our study confirms that TRM is associated with the occurrence of hypoglycaemia in elderly or predisposed patients, with characteristics similar to those previously reported with DXP. © 2012 The British Pharmacological Society. Source

Markey K.,UK National Institute for Biological Standards and Control | Ho M.M.,UK National Institute for Biological Standards and Control | Choudhury B.,UK National Institute for Biological Standards and Control | Seki M.,Japan BCG Laboratory | And 7 more authors.
Vaccine | Year: 2010

Current methods for the identification of BCG vaccine in quality control settings involve acid-fast staining with microscopic examination. However, this method is unable to distinguish the many different sub-strains of BCG, or to differentiate BCG strains from virulent members of the Mycobacterium tuberculosis complex. A multiplex PCR (mPCR) which uses six target regions in mycobacteria has been developed to identify specific sub-strains of BCG. This study reports the findings from an international collaborative study to assess the accuracy, robustness and reproducibility of this mPCR method to differentiate BCG sub-strains. The method was found to fulfil these criteria successfully and was able to distinguish BCG sub-strains in vaccine preparations. The majority of the participants in the study generated the expected PCR product profiles indicating the method is also robust. © 2010 Elsevier Ltd. Source

Gravanis I.,European Medicines Agency | Ersboll J.,Laegemiddelstyrelsen | Skovlund E.,Statens Legemiddelverk | Abadie E.,Agence Francaise de Securite Sanitaire des Produits de Sante | Pignatti F.,European Medicines Agency
Oncologist | Year: 2010

On April 19, 2010, the European Commission issued a conditional marketing authorization valid throughout the European Union (EU) for ofatumumab (Arzerra®; Glaxo Group Ltd, Greenford, Middlesex, U.K.). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human Use recommending a conditional marketing authorization for ofatumumab for the treatment of chronic lymphocytic leukemia (CLL) in patients refractory to fludarabine and alemtuzumab. A conditional marketing authorization means that additional data to confirm the benefit-risk balance of ofatumumab are awaited. The active substance of Arzerra® is ofatumumab, a monoclonal antibody medicinal product (ATC code L01XC10). The recommended dose is 300 mg of atumumab for the first infusion and 2,000 mg of atumumabfor all subsequent infusions. The infusion schedule is eight consecutive weekly infusions, followed 4-5 weeks later by four consecutive monthly (i.e., every 4 weeks) infusions. Ofatumumab targets CD20, a cell surface marker of B lymphocytes, which is followed by cell lysis via complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. The benefit of ofatumumab is the control of CLL in patients who are refractory to both fludarabine and alemtuzumab, which was indicated by a high response rate. The most common side effects are infections and infusion reactions. The objective of this paper is to summarize the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMAwebsite (http://www.ema.europa.eu). © AlphaMed Press. Source

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