View clinical trials related to Influenza.
Filter by:Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Such data would be important in determining the contribution of influenza to the more than two million annual pneumonia deaths among children globally, mostly in the developing world, and the potential number of deaths that could be prevented by influenza vaccination. A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective in preventing influenza in healthy older children and young and middle-aged adults, but is less efficacious in young children and the elderly. Young children who suffer substantial influenza morbidity and are unlikely to have pre-existing immunity should receive two doses of TIV to provide adequate immunity. Because family studies of influenza transmission conducted during the 1970's found children to be the main introducers of influenza into households, vaccination of children may decrease the chances of spreading influenza to contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory illness in unvaccinated persons suggesting that immunization of children on a larger scale can affect community epidemics. In temperate industrialized countries with seasonal disease, influenza vaccine is given annually, prior to the influenza season, and generally targeted to individuals with the highest risk of severe disease. Influenza prevention strategies may need to differ in tropical developing countries due to a variety of reasons. Given the varying influenza circulation patterns, it is unknown which hemisphere vaccine formulation will provide year-round protection against the diverse strains that may exist in tropical countries. Persons residing in developing countries also may have nutritional deficiencies or underlying diseases and infections that affect vaccine immunogenicity. Consideration must be given to programmatic issues as well. Adolescent and adult preventive health services are poorly developed in many countries, and thus a strategy that targets children may be the most feasible option. In addition, vaccinating children may be the most cost-effective option, as it has the potential to provide direct benefit to those vaccinated, as well as indirect benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness study in a tropical developing country population will help to elucidate burden of seasonal influenza and may inform optimal use of vaccine for either seasonal and pandemic situations. Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the occurrence of laboratory-confirmed influenza among children who receive it as well as the potential indirect effects experienced by the population as a result of reducing transmission among children.
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: - To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. - To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. - To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives: - To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. - To describe the immune response after each vaccination in subjects receiving study vaccine.
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.
The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women?
The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated locally and systemically and by using haematological, biochemical and immunological screening tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local and systemic antibody and cellular immune responses. In a pandemic situation, an important aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of the immune response will be investigated. The capacity of the vaccine to elicit long lasting immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the quality of the immune response induced by the vaccine will be studied. The vaccine will be administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating doses will be separated by a period of one week. Four groups each containing 15 subjects will receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing: Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM.