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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Biological: influenza vaccine Fluarix, Adjuvanted Fluarix
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: October 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318058

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
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: NCT00318058     History of Changes
Other Study ID Numbers: 104540
Study First Received: April 25, 2006
Last Updated: September 29, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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 May 22, 2013