DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Mar 20, 2014

Keywords

ClinConnect Summary

Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP\~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP\~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.

Gender

ALL

Eligibility criteria

• 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.