immunogenicity and safety of tetraxim™ given as a booster dose at 4 to 6 years of age

Conditions: Diphtheria; Tetanus; Pertussis; Poliomyelitis

Summary: the purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's dtacp-ipv combined vaccine (tetraxim™) as a booster dose during the 4th and 6th year of life in children that previously received in study e2i34 (nct 00255021), sanofi pasteur dtacp-ipv// prp\~t vaccine (pentaxim™) as a three-dose primary and booster vaccinations. primary objective : * to assess immunogenicity in terms of seroprotection rates (diphtheria, tetanus, polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular pertussis antigens (pertussis toxoid \[pt\], filamentous haemagglutinin \[fha\]) of sanofi pasteur's dtacp-ipv (tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. secondary objectives : * to describe the antibody persistence in terms of anti-pertussis antibody levels (anti-pt, and -fha) and in terms of seroprotection rates and gmts for diphtheria, tetanus, and poliovirus types 1, 2 and 3, just before administration of the booster dose (at visit 1) in all subjects at 4-6 years of age. * to assess immunogenicity in terms of seroprotection rates (diphtheria, tetanus, polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular pertussis antigens (pt, fha) of sanofi pasteur's dtacp-ipv (tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age. * to describe the safety after the booster dose of the study vaccine.

all participants that previously completed the three-dose primary and the booster vaccinations in the study e2i34 (nct 00255021) will be contacted to enroll in this study to receive sanofi pasteur's dtacp ipv combined vaccine (tetraxim™) at 4 to 6 years of age. participants will receive the study vaccine \[sanofi pasteur's dtacp-ipv vaccine (tetraxim™)\] at 4 to 6 years of age (at visit 1).

Eligibility criteria:
inclusion criteria : * aged 4-6 years inclusive on the day of inclusion * child having completed the three-dose vaccination and the booster vaccination with dtacp-ipv//prp\~t combined vaccine (pentaxim™) of the study e2i34 * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria : * participation in another clinical trial in the 4 weeks preceding the trial inclusion * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) * any vaccination in the 4 weeks preceding the trial vaccination * history of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically) * clinical or known serological evidence of systemic illness including hepatitis b, hepatitis c and/or human immunodeficiency virus (hiv) infection * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study e2i34 * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current major neurological diseases or seizures * febrile illness (temperature ≥ 38°c) or acute illness on the day of inclusion. * serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as * encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine, * temperature more than 39.5°c within 48 hours following vaccine injection, not due to another identifiable cause * inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection, * hypotonic hyporesponsive episode within 48 hours following vaccine injection, * seizures with or without fever within 3 days following vaccine injection.

Keywords: diphtheria tetanus pertussis poliomyelitis pentaxim™ tetraxim™