This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,332
GSK Investigational Site
Tucson, Arizona, United States
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Time frame: One month after vaccination.
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
Time frame: Before (PRE) and one month after vaccination (POST)
Anti-T and Anti-D Antibody Concentrations
Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
Time frame: Before (PRE) and one month after vaccination (POST)
Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Booster response defined as : For initially seronegative subjects (\< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination. For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Time frame: One month after vaccination
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Booster response defined as : For initially seronegative subjects (\< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination. For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration \< 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
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GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
DeLand, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Pratt, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Columbia, Maryland, United States
...and 14 more locations
Time frame: One month after vaccination
Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
Vaccine response using alternative definitions defined as: For initially seronegative subjects (\< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination. For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration.
Time frame: One month after vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
Time frame: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
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.
Time frame: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, 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.
Time frame: From the vaccination up to Day 182