study of dtap-ipv-hep b-prp~t combined vaccine in indian infants previously given a dose of hepatitis b vaccine at birth

Conditions: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Invasive Hib Infections

Summary: the purpose of this study is to describe the immunogenicity and safety of a novel dtap- ipv- hep b-prt\~t fully liquid combined hexavalent vaccine (hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis b surface antigen (hbsag) serology negative in india. primary objective: * to evaluate the immunogenicity of the study vaccine in terms of seroprotection \[diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, haemophilus influenzae type b (hib) polysaccharide (prp), hepatitis b (hep b)\] and vaccine response for pertussis antigens \[pertussis toxoid (pt) and filamentous haemagglutinin (fha)\] one month after the third dose. secondary objectives: * to further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose. * to describe the safety after each and any doses of the study vaccine.

all participants will receive a total 4 doses of hep b, i.e. one dose of hep b monovalent vaccine given at birth followed by 3 doses of sanofi pasteur's hexavalent vaccine given at 6, 10 and 14 weeks of age in the context of the study. participants and parents will attend four clinic visits; the expected participation in the study is approximately 3 months.

Eligibility criteria:
inclusion criteria: * aged between 42-56 days (6 to 8 weeks) on the day of inclusion * born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * informed consent form signed by the parent(s) or any other legally acceptable representative * subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures * born to known hepatitis b surface antigen (hbsag) seronegative mother (documented laboratory result of hbsag assay from maternal blood sample performed during last trimester of pregnancy available) * have received one documented dose of hep b vaccine and oral poliovirus vaccine (opv) from birth as per national recommendations. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except bacillus calmette-guerin \[bcg\] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of opv as per national recommendations) and hepatitis b (except the birth dose of hep b vaccine) diseases or hib infection with the trial vaccine or another vaccine * past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) * history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, or hib infections (confirmed either clinically, serologically or microbiologically) * known personal or maternal history of human immunodeficiency virus (hiv) or hepatitis c seropositivity * 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 * known thrombocytopenia, as reported by the parent/legally acceptable representative * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * in an emergency setting, or hospitalized involuntarily * chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥38°c) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided) * identified as a natural or adopted child of the investigator, relatives or employee with direct involvement in the proposed study * history of seizures.

Keywords: diphtheria tetanus whooping cough hepatitis b poliomyelitis dtap ipv-hep b-prp~t combined vaccine (hexaxim™)