At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
In Brief
A Phase 2 clinical trial evaluating SB218352_15, SB218352_8, and 5 other interventions for Influenza and Influenza Vaccines. Completed, enrolled 385 participants across 10 sites.
Detailed Summary
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.
Study Details
Timeline
Interventions
Non-adjuvanted pandemic influenza A formulation 1 vaccine
Non-adjuvanted pandemic influenza A formulation 2 vaccine
Non-adjuvanted pandemic influenza A formulation 3 vaccine
Non-adjuvanted pandemic influenza A formulation 4 vaccine
Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine