Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Launched by SANOFI · Oct 4, 2010

Keywords

ClinConnect Summary

All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 2 months (56 to 70 days) inclusive on the day of inclusion
• • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
• • Informed consent form signed by the parent(s) or other legal representative
• • Able to attend all scheduled visits and to comply with all trial procedures
• Exclusion Criteria:
• • Participation in another clinical trial in the 4 weeks preceding the trial inclusion
• • Planned participation in another clinical trial during the present trial period
• • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids therapy
• • Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
• • Chronic illness at a stage that could interfere with trial conduct or completion
• • Blood or blood derived products received in the past or current or planned administration during the trial (including immunoglobulins).
• • Any vaccination in the 3 weeks preceding the first trial vaccination.
• • History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically).
• • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
• • Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
• • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• • History of/current major neurological diseases or seizures.
• • Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion.
• • Known family history of congenital or genetic immuno-deficiency.