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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection, Poliomyelitis
Interventions: DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
Countries: South Korea
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP\~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP\~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative. Primary Objective * To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid \[PT\] and filamentous haemagglutinin \[FHA\]) of Group A versus Group B, one month after the third dose of combined vaccines. Secondary Objectives: * To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines. * To study the safety after each and any dose of vaccines administered in the two vaccination schemes
Sex: ALL
Age: 1 Month to 6 Months
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Aged 30 to 40 days on the day of the first study visit * 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(s) or other legally acceptable representative * Participant 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 the maternal blood sample is available) * Have received one documented dose of Hep B vaccine at birth according to the national recommendations. Exclusion Criteria: * Participation 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 any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either 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) * Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically * 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 * 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 (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 * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * History of seizures.
- Daejeon, South Korea
- Gyeonggi-do, South Korea
- Gyeonggi-do, South Korea
- Gyeongsangnam Do, South Korea
- Gyeongsangnam Do, South Korea
- Jeollabuk Do, South Korea
- Jeonbuk, South Korea
- Kangwon Do, South Korea
- Kyunggi Do, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Suwon Gyeonggi Do, South Korea