View clinical trials related to Influenza, Human.
Filter by:This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune response than the seasonal TIV alone.
Study objectives are to compare - influenza antibody levels in infant sera and maternal colostrum or breast milk at delivery, 2, and 6 months women who receive influenza immunization in early pregnancy, late pregnancy, or no influenza immunization during pregnancy and their infants Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have - higher levels and a longer serum influenza antibody duration in sera (hemagglutination inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early pregnancy or not immunized
The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.
The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body. HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age). Primary Objective: - To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants. Secondary Objectives: - To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency) - To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over. The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV) is that the immune system will be stimulated to produce both influenza specific T cells and influenza specific antibodies.
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.
The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.