sequential inactivated poliomyelitis vaccine followed by oral poliomyelitis vaccine versus oral poliomyelitis vaccine

Conditions: Polio; Poliomyelitis

Summary: the purpose of this study is to generate data to support the registration extension of imovax polio to be used in a sequential vaccination. primary objective: * to demonstrate the non-inferiority of inactivated poliomyelitis vaccine (ipv)-(oral poliomyelitis vaccine) (opv)-opv (sequential 1) and ipv-ipv-opv (sequential 2) poliovirus vaccine administrations versus opv-opv-opv (reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series. secondary objectives: * to evaluate the safety profile of the investigational vaccines after each administration in each group. * to describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group. * to describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

study participants will be randomized to receive either 3 doses of a commercially available oral poliovirus vaccine (opv), or 1 dose of sanofi pasteur's injectable inactivated poliovirus vaccine imovax polio (ipv) followed by 2 doses of opv, or 2 doses of ipv followed by 1 dose of opv. these vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for the prevention of poliomyelitis. participants will be followed up through their 18th- to 19th-month birthday.

Eligibility criteria:
inclusion criteria: * aged ≥2 months and less than 3 months on the day of first study vaccine administration * born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * informed consent form has been signed and dated by the parent or other legally acceptable representative * subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except diphtheria, tetanus, acellular pertussis vaccine \[dtap\], haemophilus influenzae type b \[hib\] vaccine, bacille calmette-guerin vaccine \[bcg\] and hepatitis b given at least 7 days before and after study vaccination)previous vaccination against poliomyelitis with either the trial vaccine or another vaccine * receipt of immune globulins, blood or blood-derived products since birth * 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) * congenital or acquired immunodeficiency in close contacts to the subjects * history of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) * at high risk for human immunodeficiency virus (hiv) infection during the trial * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * laboratory-confirmed or otherwise known thrombocytopenia, contraindicating intramuscular vaccination * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * deprived of freedom by an administrative or court order, or 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 ≥37.1°c). 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 or employee with direct involvement in the proposed study * any other contraindication as listed in the study vaccines' leaflets.

Keywords: polio poliovirus oral poliovirus vaccine imovax polio®