drugset
drugset / Trial / NCT01201902

A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

NCT01201902 ↗

Phase 3 Completed 592 enrolled Green Cross Corporation
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Timeline

Start
2009-10
Primary completion
2009-12
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Adjuvanted influenza A(H1N1) vaccine Vaccine 0.25 ml Intramuscular
Subject Adjuvanted influenza A(H1N1) vaccine Vaccine 0.5 ml Intramuscular
Comparator un-adjuvanted influenza A(H1N1) vaccine Vaccine 0.5 ml Intramuscular

Indications

influenza