drugset / Trial / NCT00562237

Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine

NCT00562237 ↗

Phase 1 Terminated 400 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupDouble-blindPrevention

Summary

Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.

Timeline

Start
2007-07
Primary completion
2007-11
Completion
2008-09

Outcome

Outcome not reported

Stopped: “This trial discontinued on 20 JUN 2008 because the interim immunogenicity results do not justify these formulations as pandemic vaccine candidates”

Drugs

EvaluationDrugModalityDoseRoute
Subject S205 Unknown 10 ug Intramuscular
Subject S205 Unknown 30 ug Intramuscular
Subject aluminium hydroxide Other / unclassified 500 ug Intramuscular
Subject aluminium hydroxide Other / unclassified 1250 ug Intramuscular

Indications

No indication recorded.