A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
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.
|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|
- 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
- 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.
|Study Start Date:||December 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Old Bulk
This group receives a full dose of Fluviral made from aged bulk material
One dose, Intramuscular injection
Active Comparator: New Bulk
This group receives a full dose of Fluviral made from new material
One dose, Intramuscular injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586469
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|