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

A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476307

Enrollment

120

Registered

2007-05-22

Start date

2007-06-30

Completion date

2007-07-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Flu vaccine

Brief summary

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.

Interventions

BIOLOGICALFluarix™/Influsplit SSW® 2007/2008

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Immune response 21 days post vaccination	—

Secondary

Measure	Time frame
Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026