Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

Exclusion Criteria

• •Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
• •History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life.
• •Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
• •Poliovirus vaccination with one or more doses of OPV vaccine.
• •Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
• •Chronic administration or administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
• •Administration of immunoglobulins and/or any blood products within three months prior to study vaccination or planned administration during the study period ending at Day 30.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• •History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
• •Major congenital defects or serious chronic illness.
• •Acute disease at the time of enrollment.
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
• •History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
• •Encephalopathy within 7 days of administration of previous dose of Infanrix.
• •Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix not due to another identifiable cause.
• •Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of previous dose of Infanrix.
• •Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred within 48 hours of administration of previous dose of Infanrix.
• •Thrombocytopenia following a previous dose of M-M-RII or its component vaccines.
• •Inability to contact a parent/guardian of the subject by telephone.
• •Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• •Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject was demonstrated.