Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00380211
First received: September 21, 2006
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.


Condition Intervention Phase
Influenza
Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains)
Biological: Fluarix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 21 days after vaccination: seroconversion rate, seroprotection rate,
  • geometric mean titer fold increase

Secondary Outcome Measures:
  • Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
  • SAEs over the whole study period

Estimated Enrollment: 600
Study Start Date: September 2006
Study Completion Date: November 2006
Intervention Details:
    Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains) Biological: Fluarix
    Other Names:
    • Influenza vaccine (A/H3N2, A/H1N1, and B strains)
    • Fluarix
Detailed Description:

This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female adults (≥18 yrs)
  • Stable health status
  • Provide informed consent
  • Access to direct phone service (NOT a pay phone or a common-use phone service)
  • Eligible females must have a negative pregnancy test

Exclusion Criteria:

  • Febrile illness (>38.0°C oral temperature)
  • High blood pressure (≥140/90 mmHg)
  • Significant acute or chronic
  • Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
  • Immunosuppressive condition (confirmed or suspected)
  • Renal impairment
  • Hepatic dysfunction
  • Complicated insulin-dependent diabetes mellitus
  • Unstable cardiopulmonary disease
  • Blood dyscrasias
  • Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
  • History of demyelinating disease
  • Active neurological disorder
  • Significant alcohol or drug abuse
  • Significant coagulation disorder (prophylactic antiplatelet medications allowed)
  • Influenza vaccine administrated within 6 months prior to study vaccination
  • Administration of any other vaccine from 30 days prior to the end of the study
  • Use of non-registered drug within 30 days prior to study vaccination
  • Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
  • History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
  • Pregnant or nursing female subjects
  • Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)
  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: NCT00380211

Locations
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, New York
GSK Investigational Site
Binghamton, New York, United States, 13901
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76135
United States, Virginia
GSK Investigational Site
Burke, Virginia, United States, 22015
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00380211     History of Changes
Other Study ID Numbers: IDB-200-001, 109249
Study First Received: September 21, 2006
Last Updated: October 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Influenza vaccine
Thimerosal reduced content
Young and elderly adults
Immunogenicity, safety, reactogenicity

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 18, 2014