Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Novartis

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Comparator influenza vaccine

Biological: Influenza virus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00464672

IND: 13299

V71P5

Details and patient eligibility

About

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Enrollment

1,893 patients

Sex

All

Ages

3 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects 3 to 64 years of age

Exclusion criteria

Receipt of other investigational products within 3 months or other vacine within 1 month;
Allergy to eggs, egg products, or any other vaccine component;
Laboratory confirmed influenza disease within 6 months;
Have previously received an influenza vaccination (3 to 8 years only);