Tetanus Clinical Trial
Official title:
Evaluation of Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting
The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, 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 = NCT00109330).
Subjects were previously vaccinated with either Boostrix or a control Td vaccine in study
NCT00109330. Only subjects who were part of the primary study will be invited to participate
in this study. All subjects will receive a single dose of Boostrix at Visit 1 (Day 0) and
subjects will be observed till Visit 2 (Day 30) for safety in terms of solicited adverse
events (during 4 days post vaccination), unsolicited adverse events (during 31 days post
vaccination) and serious adverse event (during the trial period). A blood sample will be
collected from all subjects before vaccination (Visit 1) and one month after vaccination
(Visit 2) for antibodies estimation.
This summary has been updated following Protocol amendment 2 dated 03 October 2013. The
protocol is being amended to facilitate enrolment by:
- - Extending the window period for re-vaccination from ± 6 months to ± 300 days from the
Year 10 time point.
- - Extending the recruitment period from 6 months to 14 months. The format of
non-inferiority criterion of the first co-primary objective has been updated to keep it
aligned with the format of non-inferiority criterion of the second co-primary objective.
;
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