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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: May 21, 2007
Last updated: September 29, 2011
Last verified: September 2011

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.

Condition Intervention Phase
Biological: Fluarix™/Influsplit SSW® 2007/2008
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune response 21 days post vaccination

Secondary Outcome Measures:
  • Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events

Estimated Enrollment: 120
Study Start Date: June 2007
Study Completion Date: July 2007
Intervention Details:
    Biological: Fluarix™/Influsplit SSW® 2007/2008
    Other Name: Fluarix™/Influsplit SSW® 2007/2008

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00476307

GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00476307     History of Changes
Other Study ID Numbers: 110221
Study First Received: May 21, 2007
Last Updated: September 29, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Flu vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on April 16, 2014