Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318149
First received: April 25, 2006
Last updated: December 16, 2010
Last verified: December 2010
  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 vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.


Condition Intervention Phase
Influenza
Biological: Fluarix, 4 adjuvanted candidate influenza vaccines
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Demonstrate the Non Inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 y & Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 y)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To demonstrate the non inferiority 21 d post-vaccination of the influenza adjuvanted vaccines administered in elderly subjects (aged 65 y and older) [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
  • as compared to Fluarix™ administered in adults (aged 18-40 y) in terms of cellular mediated immune response. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and reactogenicity of vaccination with adjuvanted influenza vaccines during 21 d following the intramuscular administration of the vaccine [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
  • in elderly subjects (aged 65 y and older). Fluarix will be used as reference. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
  • To evaluate the humoral immune response (anti-haemagglutinin titre) 21,90 and 180d after vaccination with influenza adjuvanted candidate vaccines. [ Time Frame: 21, 90 and 180 days post vaccination ] [ Designated as safety issue: No ]

Enrollment: 425
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Fluarix, 4 adjuvanted candidate influenza vaccines
    Other Names:
    • Fluarix
    • 4 adjuvanted candidate influenza vaccines
  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 between 18 and 40 years or aged 65 years or older at the time of the vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

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
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: NCT00318149

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: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00318149     History of Changes
Other Study ID Numbers: 104886
Study First Received: April 25, 2006
Last Updated: December 16, 2010
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 August 21, 2014