a study of dtap-ipv-hep b-prp-t vaccine given with prevenar™ and rotarix™ in healthy latin american infants

Conditions: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Summary: the purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent dtap-ipv-hep b-prp-t vaccine compared to a control vaccine, infanrix hexa™ when given along with prevenar™ and rotarix™ vaccines. primary objectives: * to demonstrate the equivalence of immunogenicity of 3 lots of dtap-ipv-hep b-prp-t vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with prevenar™ and rotarix™, in terms of immunoresponses. * to demonstrate the non-inferiority of the hexavalent dtap-ipv-hep b-prp-t vaccine to the licensed hexavalent infanrix hexa vaccine when given with prevenar™ and rotarix™. secondary objectives: * to describe in each group the immunogenicity parameters for all antigens for each vaccine * to assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, infanrix hexa™, administered with prevenar™ at 2, 4, and 6 months of age and rotarix™ at 2 and 4 months of age. all participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Eligibility criteria:
inclusion criteria : * two month old infants (55 to 65 days old) on the day of inclusion. * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. * informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements. * able to attend all scheduled visits and to comply with all trial procedures. * received hepatitis b and bacille de calmette-guérin (bcg) vaccines between birth and one month of life in agreement with the national immunization calendar. exclusion criteria : * participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy. * known 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, in the opinion of the investigator. * blood or blood-derived products received since birth that might interfere with the assessment of the immune response. * any vaccination before trial vaccination (except hepatitis b and bacille de calmette guérin given at birth). * any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines). * documented history of pertussis, tetanus, diphtheria, poliomyelitis, haemophilus influenzae type b or hepatitis b infection(s) (confirmed either clinically, serologically or microbiologically). * previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or haemophilus influenzae type b infections. * known personal or maternal history of human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c seropositivity. * known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (im) vaccination. * history of seizures or encephalopathy. * febrile illness (temperature ≥ 38.0°c), or moderate or severe acute illness/infection on the day of inclusion, according to the investigator judgment.

Keywords: diphtheria tetanus whooping cough hepatitis b poliomyelitis diphtheria-tetanus-acellular pertussis vaccines