drugset / Trial / NCT00306995

Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

NCT00306995 ↗

Phase 2 Completed 385 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2005-05-11
Primary completion
2006-07-04
Completion
2006-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject SB218352_15 Vaccine — —
Subject SB218352_2 Vaccine — —
Subject SB218352_2AL Vaccine — —
Subject SB218352_4 Vaccine — —
Subject SB218352_4AL Vaccine — —
Subject SB218352_8 Vaccine — —
Subject SB218352_8AL Vaccine — —

Indications