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The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Baxter Healthcare Corporation
Published on BioPortfolio: 2014-08-27T03:43:37-0400
The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study wi...
The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a s...
The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost sched...
The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005
The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day ...
Egg-based influenza vaccines could be less effective than cell-based vaccine due to adaptive mutations acquired for growth. We conducted a test-negative case-control study at Kaiser Permanente Souther...
: The authors conducted an in-depth phylogenetic analysis of the hemagglutinin (HA) gene of A(H3N2) identified during the 2016-2017 season to compare the circulating strains with both the egg-derived ...
Influenza is a highly contagious viral pathogen with more than 200,000 cases reported in the U.S. during the 2017-2018 season. Annual vaccination is recommended by the World Health Organization with t...
: The current study aimed to evaluate the prevalence, level of knowledge and attitudes to seasonal influenza vaccination among older adults in Jordan.: This was a cross-sectional study in which a clos...
There are limited published data about the circulation of influenza B/Victoria and B/Yamagata in Latin America and the Caribbean (LAC) and most countries have a vaccine policy that includes the use of...
A CELL LINE derived from the kidney of the African green (vervet) monkey, (CERCOPITHECUS AETHIOPS) used primarily in virus replication studies and plaque assays.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)
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 vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.
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...
A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. It creates immunity but does not cause the disease. There are several differnt types of vaccine avalable; Killed microorganisms; which s...
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...