Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00345904
First received: June 28, 2006
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years.

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.


Condition Intervention Phase
Influenza
Biological: Fluarix
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in People Aged 18 Years or Above

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination

Secondary Outcome Measures:
  • To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events

Estimated Enrollment: 120
Study Start Date: July 2006
Intervention Details:
    Biological: Fluarix
    Other Name: Fluarix
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged 18 years or above at the time of the vaccination;
  • Healthy subjects or with well-controlled chronic diseases;
  • If the subject is female, she must be of non-childbearing potential

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Administration of an influenza vaccine within 6 months preceding the study start.
  • Administration of an influenza vaccine other than the study vaccine during the entire study
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Not stabilized or clinically serious chronic underlying disease
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345904

Locations
Germany
GSK Investigational Site
Dresden, Sachsen, Germany, 01277
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00345904     History of Changes
Other Study ID Numbers: 107507
Study First Received: June 28, 2006
Last Updated: September 29, 2011
Health Authority: Germany: Federal Agency for Sera and Vaccines

Keywords provided by GlaxoSmithKline:
influenza, vaccine
prophylaxis of influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014