Who is sponsoring NCT00522067?

NCT00522067 is sponsored by Novartis Vaccines.

What condition does NCT00522067 study?

NCT00522067 studies Influenza Disease.

What drugs are being tested in NCT00522067?

Interventions: Adjuvanted influenza vaccine.

What is the status of NCT00522067?

NCT00522067 is currently COMPLETED.

Last reviewed 2016-11-30 · How we verify

A Phase II, Open Label, Uncontrolled, Multi-Center Study to Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases

NCT00522067 Phase 2 COMPLETED

This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	COMPLETED
Enrolment	52
Start date	2007-06
Completion	2007-07

Conditions

Influenza Disease

Interventions

Adjuvanted influenza vaccine

Primary outcomes

Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.

Countries

Italy