drugset / Trial / NCT01408290

Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People

NCT01408290 ↗

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Timeline

Start
2011-09
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject FAB-3511 Vaccine 3.5 ug Intramuscular
Subject FAB-6011 Vaccine 6 ug Intramuscular
Subject FAB-9011 Vaccine 9 ug Intramuscular
Subject Fluval AB Vaccine 15 ug Intramuscular

Indications