A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363870
First received: August 10, 2006
Last updated: March 22, 2012
Last verified: March 2012

August 10, 2006
March 22, 2012
September 2006
December 2006   (final data collection date for primary outcome measure)
occurrence of confirmed influenza
Same as current
Complete list of historical versions of study NCT00363870 on ClinicalTrials.gov Archive Site
  • occurrence of influenza like illness
  • Occurrence of pneumonia
  • Immune response at days 0 and 21
  • Safety during 7 Months
Same as current
Not Provided
Not Provided
 
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Influenza
Biological: Fluarix vaccine
Other Name: Fluarix vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7632
Not Provided
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female age between 18 and 64 years at the time of the first vaccination.
  • non-childbearing female

Exclusion Criteria:

  • Use of non-registered products
  • Pregnancy
  • Hypersensitivity to a previous dose of influenza vaccine
  • Acute disease at the time of enrolment/vaccination.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine
  • Administration of any other influenza vaccine for the season 2006-2007
  • Chronic disorders of the pulmonary or cardiovascular system, including asthma.
  • Administration of immune-modifying drugs
  • Administration of immunoglobulins and/or any blood products
  • History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Finland
 
NCT00363870
108134
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP