The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
116
Intramuscular, single dose
Intramuscular, single dose
Intramuscular, single dose or 2 doses (in the annex phase)
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)
Occurrence of solicited local adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of solicited general adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of unsolicited symptoms
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Occurrence of any serious adverse experiences
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Time frame: At pre-vaccination (Day 0) and Month 1 post-vaccination
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: One month after the second and third booster dose (Month 12)
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
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Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose