drugset

drugset / Trial / NCT01153685

Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

NCT01153685 ↗

Phase 3 Completed 120 enrolled GlaxoSmithKline

Non-randomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Timeline

Start: 2010-07-09
Primary completion: 2010-07-31
Completion: 2010-07-31

Publications

Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluviral	Vaccine	—	Intramuscular

Indications