Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: - A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination - Documented administration of a hepatitis B vaccine dose at birth - Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol - Written informed consent obtained from the parent(s)/LAR(s) of the subject - Healthy subjects as established by medical history and clinical examination before entering into the study - Born after a gestation period of at least 36 weeks Exclusion Criteria: The following criteria should be checked at the time of study entry. Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines.Number of Subjects With Serious Adverse Events (SAEs)ĭuring the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)) Number of Subjects With Unsolicited Adverse Events (AEs)ĭuring the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group) Number of Subjects With Solicited General Symptoms Number of Subjects With Any Solicited Local Symptomsĭuring the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group) Number of Seroprotected Subjects Against Anti-HBs AntigensĪnti-Polio Types 1, 2 and 3 Antibody Titers Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)Īnti-D and Anti-T Antibody ConcentrationsĪnti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens Number of Seroprotected Subjects Against Hepatitis B (HBs) One month post Dose 3 (Month 3 or Month 5) Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
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