Clinical Trial: Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.
Brief Summary: 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.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value [ Time Frame: One month after vaccination. ]
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
- Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration [ Time Frame: Before (PRE) and one month after vaccination (POST) ]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)
Original Primary Outcome: Immunogenicity of study vaccine antigens. [ Time Frame: One month after vaccination. ]
Current Secondary Outcome:
- Anti-T and Anti-D Antibody Concentrations [ Time Frame: Before (PRE) and one month after vaccination (POST) ]Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.
- Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off [ Time Frame: One month after vaccination ]
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.
- Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off [ Time Frame: One month after vaccination ]
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.
- Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions. [ Time Frame: One month after vaccination ]
Vaccine response 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.
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]Solicited local symptoms assessed include pain, redness and swelling.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever
- Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) 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: From the vaccintation up to Day 182 ]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.
Original Secondary Outcome:
- Immunogenicity of study vaccine antigens. [ Time Frame: One month after vaccination. ]
- Booster responses of study vaccine antigens. [ Time Frame: One month after vaccination. ]
- Booster responses to study vaccine antigens using alternative definitions. [ Time Frame: One month after vaccination ]
- The occurrence of solicited local symptoms during the follow-up period after vaccination. [ Time Frame: 4-days following vaccination. ]
- The occurrence of solicited general symptoms during the follow-up period after vaccination. [ Time Frame: 4-days following vaccination. ]
- The occurrence of unsolicited symptoms during the days following vaccination. [ Time Frame: 31-days following vaccination. ]
- The occurrence of Serious Adverse Events (SAEs) during the active phase and extended safety follow-up phase. [ Time Frame: 31 days and 6 months following vaccination. ]
Information By: GlaxoSmithKline
Dates:
Date Received: February 2, 2009
Date Started: February 2009
Date Completion:
Last Updated: October 6, 2016
Last Verified: October 2016