drugset / Trial / NCT00559975

Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

NCT00559975

Phase 1 Completed 60 enrolled Novartis Novartis Vaccines · collab
RandomizedParallel-groupSingle-blindPrevention

Summary

To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.

Timeline

Start
2007-10
Primary completion
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluad Vaccine 0.5 ml Intramuscular
Comparator Subunit influenza vaccine Vaccine 0.5 ml
Subject agatolimod Oligonucleotide (other) 10 ug Intramuscular
Subject agatolimod Oligonucleotide (other) 30 ug Intramuscular
Subject agatolimod Oligonucleotide (other) 100 ug Intramuscular

Indications