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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Fluviral™; Biological: Fluzone®

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
• Enrollment (Actual): 1000
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with solicited local and systemic reactogenicity symptoms	First three days after vaccination
Number of subjects reporting spontaneous adverse events	Throughout the entire study period (Day 0-42)
Immune response in terms of number of seroconverted subjects	Before (Day 0) and after (Day 21) vaccination
Immune response in terms of number of seroprotected subjects	Before (Day 0) and after (Day 21) vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off	Titres calculated as geometric mean	At Day 21 after vaccination
Immune response to components of the study vaccine in terms of mean Geometric increase		At Day 21 after vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: ID Biomedical Corporation, Quebec

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: July 4, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: IDB-707-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No