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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363870
First Posted: August 15, 2006
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 10, 2006
August 15, 2006
March 23, 2017
September 2006
June 2007   (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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Influenza
Biological: 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
June 2007
June 2007   (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)
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Finland
 
 
NCT00363870
108134
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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