Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
ID Biomedical Corporation, Quebec
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01389479
First received: July 4, 2011
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years.


Condition Intervention Phase
Influenza
Biological: Fluviral™
Biological: Fluzone®
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: Active-control Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ S/F Influenza Vaccine in Healthy Adults Aged 18-64 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with solicited local and systemic reactogenicity symptoms [ Time Frame: First three days after vaccination ] [ Designated as safety issue: No ]
  • Number of subjects reporting spontaneous adverse events [ Time Frame: Throughout the entire study period (Day 0-42) ] [ Designated as safety issue: No ]
  • Immune response in terms of number of seroconverted subjects [ Time Frame: Before (Day 0) and after (Day 21) vaccination ] [ Designated as safety issue: No ]
  • Immune response in terms of number of seroprotected subjects [ Time Frame: Before (Day 0) and after (Day 21) vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off [ Time Frame: At Day 21 after vaccination ] [ Designated as safety issue: No ]
    Titres calculated as geometric mean

  • Immune response to components of the study vaccine in terms of mean Geometric increase [ Time Frame: At Day 21 after vaccination ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: January 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluviral Group Biological: Fluviral™
Intramuscular, single dose
Active Comparator: Fluzone Group Biological: Fluzone®
Intramuscular, single dose

Detailed Description:

This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At the time of conduct of this study, Fluviral was produced by ID BioMedical.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female.
  • Adults 18-64 years of age, inclusive.
  • Satisfactory baseline medical assessment by history, physical examination, and clinical laboratory testing.
  • Capable of informed consent.
  • Able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

  • Acute illness at the time of enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection and/or chronic use of immunosuppressants of other immune-modifying drugs within 6 months of administration of the study vaccine.
  • Presence of an unstable chronic illness.
  • Complicated diabetes mellitus.
  • Active neurological disorder.
  • History of any demyelinating disease including Guillain-Barré syndrome.
  • Any clinical laboratory abnormality.
  • Any disorder of coagulation or treatment with coumadin derivatives or heparin.
  • Vital sign abnormalities at screening.
  • Acute or chronic liver, renal or inflammatory bowel disease or collagen vascular disease.
  • Cancer, or treatment for cancer, within three years.
  • History of significant alcohol or drug abuse within one year prior to the screening visit.
  • Positive urine drug screen at screening within 3 months prior to the screening visit or hard drugs. Products such as ativan, tylenol with codeine should be stopped sufficiently ahead of the screening visit in order to avoid a positive urine drug screen.
  • Positive testing for hepatitis B, hepatitis C or human immunodeficiency virus at screening.
  • Receipt of an influenza vaccine within 9 months prior to dosing.
  • Planned administration of any other vaccines 30 days before study immunization or during the course of the study. Immunization on an emergency basis, such as Tetanus and Diphtheria Toxoids Adsorbed for adult use, will be allowed provided the vaccine is not administered within two weeks prior to study immunization.
  • Use of any investigational or non-registered drug or vaccine or participation in an investigational study within 30 days prior to administration of study vaccine, or planned use during the study period.
  • Receipt of any immunoglobulins and/or any blood products within three months of screening or planned administration of any of these products during the study period.
  • Receipt of a depot injection or an implant of any drug within 3 months prior to administration of study vaccine.
  • Any known or suspected allergy to any constituent of Fluviral™ S/F or Fluzone®.
  • A history of severe adverse reaction to a previous dose of any influenza vaccine.
  • History of anaphylactic type reactions to consumption of eggs.
  • Any other condition or social circumstance that, in the opinion of the Principal Investigator, would make the subject unsuitable for or unable to complete the study.
  • Breast-feeding subject.
  • Positive urine pregnancy test at screening.
  • Female subjects having sexual intercourse with any non-sterile male partner within 14 days prior to vaccine administration and without a history of acceptable contraception.
  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: NCT01389479

Sponsors and Collaborators
GlaxoSmithKline
ID Biomedical Corporation, Quebec
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: NCT01389479     History of Changes
Other Study ID Numbers: IDB-707-105
Study First Received: July 4, 2011
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

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 September 11, 2014