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

NCT01389479 | Completed Phase 3

• 1 other identifier: IDB-707-105
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off

  At Day 21 after vaccination

• Immune response to components of the study vaccine in terms of mean Geometric increase

  At Day 21 after vaccination

Study Arms (2)

Fluviral Group

EXPERIMENTAL

Biological: Fluviral™

Fluzone Group

ACTIVE COMPARATOR

Biological: Fluzone®

Interventions

Fluviral™ BIOLOGICAL

Intramuscular, single dose

Fluviral Group

Fluzone® BIOLOGICAL

Intramuscular, single dose

Fluzone Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• ID Biomedical Corporation, Quebec: collaborator

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 8, 2011
• Study Start: January 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: June 8, 2017

Record last verified: 2017-05