Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

• Immunogenicity with respect to the components of the study vaccines [ Time Frame: Prior to the first dose and one month after the third dose of primary vaccination ] [ Designated as safety issue: No ]
• Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
• Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
• Serious adverse events [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

• Poliomyelitis
• Poliomyelitis Vaccines

• Biological: Poliorix™
  3 doses, intramuscular administration
• Biological: Oral Poliovirus vaccine
  3 doses, oral administration

• Experimental: Poliorix Group
  Subjects will be administered Poliorix™ at 2, 3 and 4 months of age.
  Intervention: Biological: Poliorix™
• Active Comparator: Control Group
  Subjects will be administered an oral poliovirus vaccine at 2, 3 and 4 months of age.
  Intervention: Biological: Oral Poliovirus vaccine

Inclusion Criteria:

• A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (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.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous or intercurrent poliomyelitis disease or vaccination.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• Child in care.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.