The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Intramuscular, single dose
Intramuscular, four doses
Intramuscular, four doses
Immunogenicity with respect to components of the study vaccines.
Time frame: One month after the first dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines.
Time frame: One month after the third dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time frame: One month after the second dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time frame: One month after the third dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time frame: One month after booster vaccination.
Occurrence of solicited local and general symptoms (on secondary readouts).
Time frame: On Day 0-Day 7 after neonatal vaccination.
Occurrence of solicited local and general symptoms (on secondary readouts).
Time frame: On Day 0-Day 3 after each dose of primary and booster vaccination.
Occurrence of unsolicited adverse events (on secondary readouts).
Time frame: On Day 0-Day 30 after each vaccination.
Occurrence of serious adverse events (on secondary readouts).
Time frame: From enrolment up to study end.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral, two doses