Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
GlaxoSmithKline
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.
Age
19–30
Sex
ALL
Healthy volunteers
Accepted
