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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389479
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : June 8, 2017
ID Biomedical Corporation, Quebec
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluviral™ Biological: Fluzone® Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluviral Group Biological: Fluviral™
Intramuscular, single dose
Active Comparator: Fluzone Group Biological: Fluzone®
Intramuscular, single dose

Primary Outcome Measures :
  1. Number of subjects with solicited local and systemic reactogenicity symptoms [ Time Frame: First three days after vaccination ]
  2. Number of subjects reporting spontaneous adverse events [ Time Frame: Throughout the entire study period (Day 0-42) ]
  3. Immune response in terms of number of seroconverted subjects [ Time Frame: Before (Day 0) and after (Day 21) vaccination ]
  4. Immune response in terms of number of seroprotected subjects [ Time Frame: Before (Day 0) and after (Day 21) vaccination ]

Secondary Outcome Measures :
  1. 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 ]
    Titres calculated as geometric mean

  2. Immune response to components of the study vaccine in terms of mean Geometric increase [ Time Frame: At Day 21 after vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389479

Sponsors and Collaborators
ID Biomedical Corporation, Quebec
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01389479     History of Changes
Other Study ID Numbers: IDB-707-105
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases