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Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00718120
First received: July 17, 2008
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.

Condition Intervention Phase
Influenza Biological: Fluviral® Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of a Single Injection of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2008 - 2009 Season) in Adults Aged 18 to 60 Years and Over 60 Years.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Hemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Day 0 and 21 ]
    Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.

  • Number of Seroconverted Subjects [ Time Frame: At Day 21 ]
    Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.

  • Number of Seroprotected Subjects [ Time Frame: At Day 0 and 21 ]
    Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.

  • Fold Increase From Baseline in Serum HI Antibody Titer [ Time Frame: At Day 21 ]
    The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ]
    Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.

  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.


Enrollment: 110
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluviral Adult Group
Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
Biological: Fluviral®
One intramuscular injection into the deltoid region of the non-dominant arm
Experimental: Fluviral Elderly Group
Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Biological: Fluviral®
One intramuscular injection into the deltoid region of the non-dominant arm

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Male and female adults, 18 to 60 years of age and over 60 years of age.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

  • Acute disease at the time of enrollment.
  • Significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Any confirmed or suspected immunosuppressive condition including:

    • History of human immunodeficiency virus (HIV) infection,
    • Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
  • History of renal impairment.
  • History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
  • Complicated insulin-dependent diabetes mellitus.
  • Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
  • Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
  • Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
  • A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
  • Presence of an active neurological disorder.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
  • Receipt of an influenza vaccine within 6 months prior to study enrollment.
  • Administration of any vaccines within 30 days prior to study enrollment or during the study period.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Any known or suspected allergy to any constituent of the vaccine.
  • A history of severe adverse reaction to a previous influenza vaccination.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
  • Lactating/nursing female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  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: NCT00718120

Locations
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110584
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00718120     History of Changes
Other Study ID Numbers: 110584
Study First Received: July 17, 2008
Results First Received: July 16, 2009
Last Updated: October 26, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Fluviral
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 16, 2017