Track topics on Twitter Track topics that are important to you
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.
This is a randomized, single-blinded study on vaccines for prevention of influenza.
Three study visits will be scheduled for each study subject, at Day 0, Day 9-11 and Day 30-35. Prior to the performance of any protocol procedures, the investigator is will obtain an informed consent from each participant.
At the first study visit (Day 0), demographic data, medical history, pre-existing conditions and concomitant medication will be recorded. Physical examination with recording of vital signs will be performed and in case of females of childbearing age, a pregnancy test will be performed. After the subject has qualified eligible, before vaccination, 60 ml venous blood will be taken for base-line immunity tests. Each subject will be randomly allocated to receive one of the three study vaccines, administered as a deep intramuscular (i.m.) injection into the deltoid muscle. The subjects will be blinded for the vaccine regimen. The principal investigator will administer the vaccines filled in ampoule or packed in pre-filled ready-to-use syringes and can thus not be blinded, but the staff and sub-investigators responsible for the routine follow-up and assessments and laboratory personnel will be blinded. A diary card will be given to each subject for recording pre-defined solicited adverse events for the vaccination day and 6 subsequent days and all other adverse events and concomitant medications.
At the second study visit (Day 9-11) the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests. A new diary card will be given to each subject for recording adverse events and concomitant medications.
At the third study visit (Day 30-35), the diary card will be collected. All adverse events and concomitant medication will be assessed and recorded. A physical examination will be performed and 60 ml venous blood shall be taken for immunity tests.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
National Health Centre
Active, not recruiting
National Centre for Epidemiology, Hungary
Published on BioPortfolio: 2014-08-27T03:13:52-0400
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivale...
This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injecti...
FLU-v is a broad spectrum influenza vaccine that targets regions in the influenza virus that are conserved among many different influenza strains.This study aims to assess efficacy of FLU-...
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. The objectives of this Phase 1 study are to test the safety of the vac...
The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in grea...
The benefit of influenza vaccines is difficult to estimate due to the complexity of accurately assessing the burden of influenza. To improve the efficacy of influenza vaccines, vaccine manufacturers h...
Vaccination against influenza is the most effective approach for reducing influenza morbidity and mortality. However, influenza vaccines are unique among all licensed vaccines as they are updated and ...
Older individuals are at high risk for morbidity and mortality due to influenza, and the most effective way to prevent influenza is yearly vaccination. In China, the influenza vaccine is not covered b...
The development of a broadly protective or universal influenza virus vaccine is currently a public health priority worldwide. The vast majority of these efforts is exclusively focused on influenza A v...
I propose that influenza vaccine failure be defined as receipt of a properly stored and administered vaccine with the subsequent development of documented influenza. Several mechanisms of vaccine fail...
Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)
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 combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.
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)
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Swine Flu - H1N1 influenza - H7N9
Swine flu is the common name given to a relatively new strain of influenza (flu) that caused a flu pandemic in 2009-2010. It is also referred to as H1N1 influenza (because it is the H1N1 strain of virus). The H1N1 flu virus will be one of the main vi...