immunogenicity and safety of boostrix polio vaccine as a booster dose in 5 to 6-year-old children.

Conditions: Acellular Pertussis; Tetanus; Diphtheria; Poliomyelitis

Summary: this phase 3b study will compare the immunogenicity and reactogenicity of the dtpa-ipv vaccine to that of a dtpa-ipv vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of dtpa-based vaccine according to the "3-5-11" month schedule recommended in italy. in this study, mmrv vaccine will also be co-administered to all children.


Eligibility criteria:
inclusion criteria: * a male or female child of 5 and 6 years of age at the time of vaccination. * subjects who received a complete 3-dose vaccination with a dtpa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in italy. * subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in italy. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * written informed consent obtained from the parent or guardian 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 within six months prior to the booster vaccine dose. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period. * 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. * previous booster vaccination against tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life. * previous measles, mumps, rubella and/or varicella second dose vaccination. * known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease. * known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. * any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period. * occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. * occurrence of any of the following adverse events after a previous administration of a dtp vaccine: * hypersensitivity reaction to any component of the vaccine; * encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine; * fever \>= 40°c within 48 hours of vaccination, not due to another identifiable cause; * collapse or shock-like state within 48 hours of vaccination; * convulsions with or without fever, occurring within 3 days of vaccination. * residence in the same household as a person high risk for varicella * the following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: * current febrile illness or axillary temperature ≥ 38.5 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: boostrix polio dtpa-ipv