NCT00306995

Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza
• Influenza Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	SB218352_15	Non-adjuvanted pandemic influenza A formulation 1 vaccine
BIOLOGICAL	SB218352_8	Non-adjuvanted pandemic influenza A formulation 2 vaccine
BIOLOGICAL	SB218352_4	Non-adjuvanted pandemic influenza A formulation 3 vaccine
BIOLOGICAL	SB218352_2	Non-adjuvanted pandemic influenza A formulation 4 vaccine
BIOLOGICAL	SB218352_8AL	Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
BIOLOGICAL	SB218352_4AL	Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
BIOLOGICAL	SB218352_2AL	Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine

Timeline

• Start date: 2005-05-11
• Primary completion: 2006-07-04
• Completion: 2006-07-04
• First posted: 2006-03-27
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

10 sites across 1 country: Germany