The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off
Timeframe: At year 1 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At year 3 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At year 5 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At Year 9, one month before the booster vaccination.
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At year 1 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At year 3 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At year 5 after the vaccination in primary study (NCT00346073)
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Timeframe: At Year 9, one month before the booster vaccination.
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Timeframe: At Year 9, one month after the booster vaccination.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Timeframe: At Year 9, one month before booster vaccination
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Timeframe: At Year 9, one month after the booster vaccination
Booster Response to D and T Antigens
Timeframe: At Year 9, one month after the booster vaccination.
Booster Response to PT, FHA and PRN Antigens
Timeframe: At Year 9, one month after the booster vaccination.