Other clinical trials
This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine
versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.
To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,
Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to
acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's
TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the
three-dose primary vaccination. Description:
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. Eligibility:
Age: 56 Days - 70 Days
- 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
- 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. Outcome:
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