Active clinical trials for "Influenza, Human"

Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).

Elderly people who have multiple health problems are at higher risk of illness from viral respiratory infections, such as influenza (the flu) and COVID-19. This is especially true for residents in long-term care because the usual methods of infection control (handwashing, mask-wearing, and distancing) are difficult to enforce due to the memory problems of many residents and the frequently shared common spaces. It can also be difficult to prevent the spread of viral infections within long-term care because many residents are unable to tell their caregivers when they are feeling ill. Also, some elderly people do not show typical symptoms of infection (like fever), instead they may suddenly become confused or weak. This study will test if a safe form of ultraviolet light (far-UVC) can be effective as an extra method of disinfection (in addition to usual manual cleaning) against airborne and surface viruses that can cause respiratory infections.

This study uses a prospective cohort design to investigate if the seasonal influenza vaccine is equally effective when given early and late before the proceeding influenza season. All health care workers will be vaccinated for seasonal influenza either 3 months before or 1 month prior to the start of the influenza season. HCWs that consent to take part in the study will have 4 blood samples taken for an antibody check. The initial antibody checks will be done just prior to vaccination as well as 2 weeks after vaccination. Subsequent samples will be taken at the peak of influenza season and at the end of the influenza season. HCWs that develop ILI during the course of the influenza season will be asked to complete a questionnaire and oropharyngeal self-swab. HCWs will also provide exhaled breath samples and wear a mask in order to evaluate novel non-invasive methods for diagnosis of influenza. Influenza positive and negative inpatients identified through the University of Leicester's laboratory system will also be asked to provide breath samples to evaluate this technique for the diagnosis of influenza.

A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.

The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.

Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant chemical called sulforaphane (SFN) which boosts production of certain "defense" enzymes that increase the activity of antioxidants. In animals, the chemical protection from SFN helps prevent diseases associated with inflammation and cancer among others, and this is currently being studied in humans. Young broccoli sprouts have a particularly high level of SFN compared to other foods. The purpose of this research study is to learn about short term responses to live attenuated influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and nonsmoking volunteers treated with broccoli sprout homogenates ("shake") or a placebo homogenate. This will be done by obtaining a series of "nasal lavages" or rinses of your nose with salt water, as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine. Using these samples, we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a placebo alfalfa spout "shake" which is low in SFN during each of 4 study visits. Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening, subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal biopsies will performed prior to and after study interventions.

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. In light of the 2009 H1N1 pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of H1N1 influenza circulating in the population. Ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. The study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.

Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved in the European Union (EU) through mutual recognition. It is indicated for treatment and prevention of influenza in adults and children over the age of 5 years. Zanamivir animal studies, conducted primarily in rabbits, showed a trend towards increased post-implantation loss, decreased fetal body weight, and increased minor fetal skeletal changes, although these effects were not statistically significant. Given the frequency, pattern and distribution of these effects, it was concluded that they were not related to zanamivir treatment. The summary of product characteristics for zanamivir states that it should not be used during pregnancy unless the potential benefit to the mother justifies the risk to the fetus. Postmarketing data have shown no higher risk of malformation with oseltamivir than in the general population, but data on zanamivir are scarcer. Limited data are available on pregnancy outcomes with maternal exposure to zanamivir during pregnancy. From 01 August 2003 through 31 January 2009, 133 women were reported to have been treated with zanamivir while pregnant. Of these 133 pregnancies, 83 pregnancies were on-going or had been lost to follow-up (62.4%) at the time of the report; 43 resulted in a live birth with no apparent congenital anomalies (32.3%), 4 represented spontaneous abortions with no apparent congenital anomalies (3.0%), 2 were elective terminations with no apparent congenital anomalies (1.5%), and 1 was an ectopic pregnancy (<1%). The European Medicines Agency (EMA) has concluded that exposure to zanamivir during pregnancy does not represent a new safety risk to the fetus. Published research has suggested that early antiviral treatment of pregnant H1N1 patients can improve outcomes. In a Center for Disease Control and Prevention (CDC) surveillance population of 788 pregnant influenza patients with disease onset between April and August 2009, the 384 with data on timing of antiviral treatment were observed to have significantly higher risk of adverse outcomes with later treatment ('intermediate', i.e. 3-4 days, n=84; 'late', i.e. > 4 days: n=81) than with early treatment (< 2 days: n=219). Compared with those given early treatment, those given intermediate treatment had almost 10 times the risk of death, and those given late treatment, more than 50 times. Intensive Care Unit (ICU) admission showed more than a 2-fold risk elevation with intermediate treatment and a six-fold elevation with late treatment, Respective elevations in risk of need for mechanical ventilation were almost 4-fold and more than 12-fold. The authors noted that the reason for treatment delays in this population are unknown, but could include reluctance on the part of clinicians and patients to expose the fetus to antiviral medications, as well as use of rapid influenza tests, which have shown low (10%-70%) sensitivity for H1N1. As part of their ongoing epidemiologic safety monitoring initiatives requested by the EMA during the influenza pandemic of 2009-2010, GSK seeks to conduct a pregnancy safety study to better understand the safety of zanamivir in women exposed during pregnancy for either the treatment or prevention of influenza. This safety study will collect information from existing European databases with records of pregnant women exposed to these products and their pregnancy outcomes in order to assess the safety of these treatments in this population. GSK is working with PPD as the contract research organization (CRO) to oversee conduct of this study, including data source management and payment, study design input, epidemiological advice, data transfer oversight and overall project management. The CRO will keep a record of all relevant personnel involved in the study. Additionally, PPD has a strategic alliance with World Health Information Science Consultants, LLC (WHISCON) (www.whiscon.com), an internationally recognized organization conducting post-approval drug safety and risk management epidemiology. WHISCON will be providing services related to protocol development as well as database-specific work plans, and will assist in analysis and interpretation of data. The primary objective of this study is to evaluate the safety of zanamivir taken during pregnancy on 1) the outcome of the pregnancy, 2) congenital anomalies identifiable at or shortly after birth, and 3) treatment-emergent diagnoses in the mother occurring within 28 days of receipt of zanamivir. The secondary objectives of this study are 1) to develop techniques for identifying influenza-like illness (ILI) in the participating data sources, and 2) to identify the characteristics of zanamivir recipients.

Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.

The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.