study of the booster effect of dtap-ipv-hep b-prp~t combined vaccine or infanrix hexa™ and prevenar™ in healthy infants

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

Summary: this is a follow-up of the primary series vaccination schedule in study a3l24 (nct01177722). the objectives are: * to describe the antibody persistence to any antigen contained in the investigational dtap-ipv-hep b-prp-t vaccine and infanrix hexa™ prior to the booster dose * to describe the safety and immunogenicity of the booster dose of either dtap-ipv-hep b-prp-t or infanrix hexa™ vaccine. * to describe the immunogenicity of a booster dose of prevenar™ given at 12 to 24 months.

all participants who completed trial a3l24 (nct01177722) will be recruited to participate in this trial. those who received dtap-ipv-hep b-prp-t combined vaccine will be randomized to receive either a booster dose of dtap-ipv-hep b-prp-t or infanrix hexa™ vaccine. those who received infanrix hexa™ will receive a booster dose of dtap-ipv-hep b-prp-t combined vaccine. all participants will receive a booster dose of prevenar™ concomitantly.

Eligibility criteria:
inclusion criteria: * aged 12 to 24 months on the day of inclusion. * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations). * subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures. * toddlers previously included in study a3l24 who completed the three-dose primary series vaccination of either dtap-ipv-hep b-prp\~t or infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with prevenar™ and rotarix™). exclusion criteria: * participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations. * planned participation in another clinical trial during the present trial period. * receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines. * planned receipt of any vaccine in the 4 weeks following the trial vaccinations. * previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, haemophilus influenzae type b, hepatitis b and pneumococcal infection(s) with either the trial vaccine or another vaccine. * receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c, as reported by the parent/guardian. * history of pertussis, tetanus, diphtheria, poliomyelitis, haemophilus influenzae type b, hepatitis b and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically. * at high risk for opportunistic infection during the trial. * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. * history of contraindication to receipt of pertussis-containing vaccine. * laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating intramuscular vaccination. * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * history of seizures . * chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. * receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw * febrile illness (temperature ≥ 38.0°c) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.

Keywords: diphtheria tetanus whooping cough hepatitis b poliomyelitis pediatric combined vaccine invasive hib infections