A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk - Full Text View

Purpose

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.

Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.

Condition	Intervention	Phase
Influenza	Biological: Fluviral	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Geometric Mean Titers (GMTs) of Anti-H3 and B Strains [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
GMTs for H1 strain is addressed as a secondary endpoint

Secondary Outcome Measures:

Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)
Number of Participants Who Seroconverted. [ Time Frame: At Day 21. ] [ Designated as safety issue: No ]
The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.
Number of Seroprotected Participants. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.
Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1 [ Time Frame: At Day 21 compared to Day 0 ] [ Designated as safety issue: No ]
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B [ Time Frame: At Day 21 compared to Day 0 ] [ Designated as safety issue: No ]
The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.

The "fold increase" corresponds to the Unit of Measure "Factor."
Number of Participants Reporting Solicited Local Symptoms [ Time Frame: During the 4-day follow up period following vaccination. ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include pain, redness and swelling.
Number of Participants Reporting Solicited General Symptoms [ Time Frame: During the 4-day period following each vaccination. ] [ Designated as safety issue: No ]
Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face
Number of Participants Reporting Unsolicited Adverse Events (AE). [ Time Frame: During the 21-day period following each vaccination. ] [ Designated as safety issue: No ]
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 Participants Reporting Serious Adverse Events (SAE) [ Time Frame: Within 21 days after vaccination ] [ Designated as safety issue: No ]
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:	1000
Study Start Date:	December 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: New Bulk This group receives a full dose of Fluviral made from new material	Biological: Fluviral One dose, Intramuscular injection
Experimental: Old Bulk This group receives a full dose of Fluviral made from aged bulk material	Biological: Fluviral One dose, Intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Male and female adults, 18 to 60 years.
Written informed consent obtained from the subject.
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.

Exclusion Criteria:

Acute disease at the time of enrollment.
Any confirmed or suspected immunosuppressive condition
Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
A history of any demyelinating disease including Guillain-Barré syndrome.
Presence of an active neurological disorder.
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
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 Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
A history of severe adverse reaction to a previous influenza vaccination.
Lactating/nursing female.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586469

Locations

Canada, British Columbia
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Newfoundland and Labrador
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M1L 4S4
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Gatineau, Quebec, Canada, J8Y 6S9
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00586469 History of Changes
Other Study ID Numbers:	111258
Study First Received:	December 21, 2007
Results First Received:	January 14, 2009
Last Updated:	April 15, 2010
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Influenza

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 May 22, 2013