drugset / Trial / NCT02307851

Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults

NCT02307851

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.

Timeline

Start
2014-11
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent VLP Vaccine Vaccine 0.5 ml Intramuscular
Comparator TIV Vaccine 0.5 ml Intramuscular

Indications