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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B
Interventions: Hexaxim®
Countries: Vietnam
The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: * To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: * To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. * To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. * To describe the persistence of all antibodies before receipt of the booster vaccination. * To evaluate the immunogenicity of the study vaccine one month after the booster.
Sex: ALL
Age: 61 Days to 91 Days
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Aged 61 to 91 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 (and by an independent witness if required by local regulations) * Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures * Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations). 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 of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion) * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion) * 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 Haemophilus influenzae type b 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 vaccine 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 * History of seizures * 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 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.
- Thái Bình, Vietnam