Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Fluarix™/Influsplit SSW® 2007/2008

Study type

Interventional

Funder types

Industry

Identifiers

NCT00476307

110221

Details and patient eligibility

About

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female aged 18 years or above;
Non-childbearing or using adequate contraception;
Written informed consent obtained from the subject.

Exclusion criteria

Subjects must not:

Participate in a trial or using non-registered product;
Use immunosuppressants, blood products, or another influenza vaccine during study;
Have virologically confirmed influenza within 1 year;
Have allergic or acute disease;
Have unstabilized serious chronic disease;
Be a lactating female.