This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
460
Intramuscular, 3 doses
Intramuscular, single dose
Intramuscular, 2 doses
GSK Investigational Site
Bruges, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Wilrijk, Belgium
Immunogenicity with respect to components of the study vaccines
Time frame: One month after the third dose (Month 7)
Immunogenicity with respect to components of the study vaccines
Time frame: One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Time frame: Within 15 days (day 0 -14) after each vaccine dose.
Occurrence of unsolicited symptoms
Time frame: Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Time frame: Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Time frame: Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken
Time frame: Within 31 days (day 0-30) after each vaccine dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intramuscular, 3 doses
GSK Investigational Site
Rotterdam, Netherlands
GSK Investigational Site
Utrecht, Netherlands
GSK Investigational Site
Alzira, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Centelles, Spain
...and 3 more locations