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Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318058
First received: April 25, 2006
Last updated: September 29, 2011
Last verified: September 2011

April 25, 2006
September 29, 2011
October 2005
November 2005   (final data collection date for primary outcome measure)
  • Percentage, intensity and relationship to vaccination of local (at the injection site) and general signs and symptoms during a 21 day follow-up period after vaccination [ Designated as safety issue: No ]
  • Occurrence of serious adverse events during the entire study. [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of local (at the injection site) and general signs and symptoms during a 21 day follow-up period after vaccination
  • Occurrence of serious adverse events during the entire study.
Complete list of historical versions of study NCT00318058 on ClinicalTrials.gov Archive Site
evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response [ Designated as safety issue: No ]
evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response
Not Provided
Not Provided
 
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population
A Phase I/II, Open, Controlled Study in Order to Evaluate the Reactogenicity and the Immunogenicity of GlaxoSmithKline Biologicals Influenza Candidate Adjuvanted Vaccine in an Elderly Population Aged Over 65 Years Previously Vaccinated in 2004 With the Same Candidate Vaccine

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after administration of the first dose of vaccine. For immunogenicity and safety evaluations, subjects who have already received Fluarix™ during the preceeding year will receive a dose of commercial vaccine and will form the control group of this trial.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: influenza vaccine Fluarix, Adjuvanted Fluarix
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
November 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or Fluarix during a clinical study organized during the preceeding year

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, 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 administration of the study vaccine.
  • History of confirmed influenza infection since a year from the date of previous vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00318058
104540
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

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