immune response and safety comparison of 3 lots of gsk biologicals' dtap-ipv candidate vaccine to dtap + ipv vaccines

Conditions: Tetanus; Acellular Pertussis; Diphtheria

Summary: the aims of this trial are to demonstrate the consistency of three manufacturing lots of gsk biologicals' dtap-ipv candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of gsk biologicals' dtap-ipv vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of gsk biologicals' dtap vaccine \[infanrix\] and aventis pasteur's ipv vaccine \[ipol\]) when administered as a 5th dose of dtap and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. vaccines will be co-administered with the second dose of m-m-rii, which is recommended at this age. concomitant administration of a us-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.

* investigational groups: 3, each receive one of 3 lots of dtap-ipv vaccine. * control: us-licensed dtap (infanrix) + us-licensed ipv (ipol) vaccines administered in separate injections. * two study visits one month apart for a subset of subjects (safety and immunogenicity subset) with a blood draw at each visit. all other subjects will have one visit. * a telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Eligibility criteria:
inclusion criteria: * male or female child between and including 4 and 6 years of age at the time of vaccination. * free of obvious health problems as established by medical history and brief medical evaluation before entering into the study. * received 4 doses of infanrix and 3 doses of ipol during the first 2 years of life. * vaccination against measles, mumps, and rubella in the second year of life. * subjects whom the investigator believed would comply with the requirements of the protocol. * written informed consent obtained before study entry from the parent(s) or guardian(s) of the subject. 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.