At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
In Brief
A Phase 3 clinical trial evaluating Adjuvanted pandemic influenza candidate vaccine, Fluarix, and 1 other intervention for Influenza. Completed, enrolled 5,075 participants across 40 sites in 7 countries.
Detailed Summary
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.
Study Details
Timeline
Interventions
2 doses, intramuscular injection
One intramuscular injection
One intramuscular injection