drugset / Trial / NCT00966238

Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age

NCT00966238 ↗

Phase 2 Completed 120 enrolled VaxInnate Corporation
NaSingle-groupOpen-labelPrevention

Summary

A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.

Timeline

Start
2009-09
Primary completion
2010-04
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject VAX125 Vaccine 0.5 ug Intramuscular
Subject VAX125 Vaccine 1 ug Intramuscular
Subject VAX125 Vaccine 2 ug Intramuscular
Subject VAX125 Vaccine 3 ug Intramuscular
Subject VAX125 Vaccine 5 ug Intramuscular
Subject VAX125 Vaccine 8 ug Intramuscular

Indications