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

GlaxoSmithKline120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Influenza

Interventions

Fluarix™/Influsplit SSW® 2007/2008BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freital, Saxony, Germany

Outcomes

Primary Outcomes

Immune response 21 days post vaccination

Secondary Outcomes

Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events

Data from ClinicalTrials.gov

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