Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
Tetanus, Acellular Pertussis, Diphtheria
About this trial
This is an interventional prevention trial for Tetanus
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
SB213503 lot 1 + M-M-R Group
SB213503 lot 2 + M-M-R Group
SB213503 lot 3 + M-M-R Group
Infanrix + IPOL + M-M-R Group
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.