Active clinical trials for "Influenza, Human"

Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the pH1N1, an increase of allergic-like reactions was observed. Passive surveillance is collecting notifications of adverse events (AE) on the whole population but the sensitivity of this system is not high and its timeliness is not necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators piloted a web-based active surveillance of a large number of health care workers (HCW) vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK, Canada). Because healthcare workers (HCW) constituted a well-defined group with general good health and received the Influenza vaccine in priority, this group of people was well suited for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited in three different sites (5183 were from Quebec). A total of 468 events (local reactions, fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430 HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded to all questionnaires. During this surveillance, the investigators didn't have unexpected findings but this active surveillance of adverse events among healthcare workers would have been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200 vaccinees. For this year the investigators want to expand the surveillance to more sites and more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to increase the response rate to all three surveys in participants. The main objective of this project is to estimate in HCW vaccinated against influenza the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation. This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto, Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to detect AE occurring at a rate of ≥ 1 per 500 vaccinees.

This study seeks to understand the host factors that affect the replication and immune response of seasonal and candidate pandemic live attenuated influenza vaccine (LAIV) in humans and to develop biomarkers that can predict the viral shedding and immune response to LAIVs.

This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza type A to type B following clinical diagnosis of influenza. Multivariate models are used to assess the effects of influenza type on clinical outcomes while accounting for potential confounders.

This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.

During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual or to use the "Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign season we will evaluate the impact of the Guide and web-based tools and assess whether there were changes in immunization rates within each organization and/or if there were significant changes in the management of the campaigns across organizations. Following completion of the study, we will work with partner organizations to make these tools available to all Canadian healthcare organizations.

This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old. Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing. Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects. Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated. The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.

The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to 15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

To monitor the safety of Shanghai Institute of Biological Products Company's influenza vaccine in subjects aged 3 years and older through Adverse Events Following Immunization Surveillance System of China. The hypothesis is that there is no significant difference in the occurrence of adverse events among influenza vaccines manufactured by SIBP and other companies.

To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd.