drugset / Trial / NCT00617851

Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

NCT00617851

Phase 3 Completed 1507 enrolled Novartis Vaccines
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

Timeline

Start
2007-11
Primary completion
2007-12
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Comparator influenza virus vaccine Vaccine Intramuscular
Subject Influenza Virus Vaccine Vaccine Intramuscular

Indications