At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Persistence Study of GSK Biologicals' Tdap Vaccine (776423), 1, 3, 5 and 9 Years Following Administration as a Single Dose in NCT00346073 Study and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
In Brief
A Phase 3 clinical trial evaluating Taking of blood samples, Boostrix, and 1 other intervention for Acellular Pertussis and 2 related conditions. Completed, enrolled 1,954 participants across 37 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.