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This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.
This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.
Enhanced vaccine safety surveillance
Not yet recruiting
Published on BioPortfolio: 2017-09-12T00:08:22-0400
The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims...
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillanc...
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivale...
The aims of this study are: 1. to investigate if HIV infection alters the antibody responses to influenza and 2. to assess the ability of licensed influenza vaccine to induce functio...
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactoge...
The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data....
The 2017/18 winter influenza season in Hong Kong SAR started in early January 2018, predominated by influenza B/Yamagata. We collaborated with private medical practitioners of our sentinel surveillanc...
The benefit of influenza vaccines is difficult to estimate due to the complexity of accurately assessing the burden of influenza. To improve the efficacy of influenza vaccines, vaccine manufacturers h...
Older individuals are at high risk for morbidity and mortality due to influenza, and the most effective way to prevent influenza is yearly vaccination. In China, the influenza vaccine is not covered b...
Influenza virologic surveillance is critical each season for tracking influenza circulation, following trends in antiviral drug resistance, detecting novel influenza infections in humans, and selectin...
Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.
A vaccine containing L1 capsid proteins from four types of HPV (ALPHAPAPILLOMAVIRUS), types 6, 11, 16 and 18 that is used to prevent infections from HUMAN PAPILLOMAVIRUSES of these subtypes.
Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.
A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)
An attenuated vaccine used to prevent and/or treat HERPES ZOSTER, a disease caused by HUMAN HERPESVIRUS 3.
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Influenza or 'flu' is a respiratory illness associated with infection by influenza virus. Symptoms frequently include headache, fever, cough, sore throat, aching muscles and joints. There is a wide spectrum of severity of illness ranging from min...