study of dtwp-hepb-hib-ipv (shan6™) vaccine administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in thailand

Conditions: Pertussis Immunisation; Diphtheria Immunisation; Polio Immunisation; Hepatitis B Immunisation; Haemophilus Influenzae Type B Immunisation; Tetanus Immunisation; Rotavirus Immunisation; Pneumococcal Immunisation

Summary: primary objective: to demonstrate the non-inferiority of the shan6™ vaccine to the licensed shan5™ given with bopv and ipv vaccines when coadministered with pcv and orv secondary objective: * to describe the immunogenicity profile of the shan6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (shan5™ given with bopv and ipv) * to describe the immune response to co-administered orv-1 (rotarix™) in a subset of participants from each group * to describe the immune response to co-administered pcv-13 (prevnar 13®) in a subset of participants from each group * to describe the persistence of the antibodies against shan6™ antigens following a 3-dose primary series of shan6™ or shan5™ given with bopv and ipv * to describe the immunogenicity profile of shan6™ 28 days after the single booster dose of shan6™ * to describe the safety profile of the shan6™ vaccine and the control vaccines (shan5™ given with bopv and ipv), when administered concomitantly with routine pediatric vaccines

the duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days) in addition to the 2 meddra terms: polio immunisation 10054175 hepatitis b immunisation 10054181 haemophilus influenzae type b immunisation 10069533 tetanus immunisation 10054131 rotavirus immunisation 10076886 pneumococcal immunisation 10069578

Eligibility criteria:
inclusion criteria : * aged ≥ 2 months (age range of 8 weeks \<12 weeks) on the day of the first vaccination * born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or medically stable prematurely born infants (born after a gestational period of 27-36 weeks) * infants who have received the birth dose of bacille calmette-guérin vaccine (bcg) at least 4 weeks before the first trial vaccination * participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures exclusion criteria: * participation at the time of study enrollment (or 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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine within the period of 4 weeks before to 4 weeks after each trial vaccination, except for oral polio vaccine (opv) and influenza vaccination. opv may be received any time during the study while influenza vaccination may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. this exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b (except the dose of hep b vaccine given at birth or at least 4 weeks before the first trial vaccination), haemophilus influenzae type b, poliomyelitis (except opv), rotavirus, and streptococcus pneumoniae with either the trial vaccines 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 at ≥ 0.5 mg/kg/day for more than 2 consecutive weeks since birth) * known personal or maternal history of human immunodeficiency virus (hiv), hepatitis b (hbsag positive), or hepatitis c (hepatitis c virus \[hcv\] ribonucleic acid \[rna\] positive) * individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, haemophilus influenzae type b, rotavirus, or pneumococcal infection(s) confirmed either clinically, serologically, or microbiologically * history of any neurologic disorders, including encephalopathy, seizures (febrile and non-febrile) and progressive neurologic disorders * history of intussusception * in an emergency setting, or hospitalized * 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 * thrombocytopenia, as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination in the investigator's opinion * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion * chronic illness that, in the investigator's opinion, is at a stage where it might interfere with trial conduct or completion * any condition which, in the investigator's opinion, might interfere with the evaluation of the study objectives * moderate or severe acute illness/infection (according to the investigator's judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 38.0 c). a prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * identified as a natural or adopted child of the investigator, relatives or employee with direct involvement in the proposed study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.