Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Age
0–0
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
At Screening:
0 to 3 day old infants
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Apgar score ≥ 7 at three minutes after birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
At Inclusion:
Six weeks of age
Received a dose of Hepatitis B (HB) in the first three days of life
Able to attend all scheduled visits and to comply with all trial procedures.
You may not be if
At Screening:
Illness at a stage that could interfere with trial conduct or completion
Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth)
Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
Acute illness on the day of screening.
At Screening and at Inclusion:
Blood or blood-derived products received since birth
Planned participation in another clinical trial during the present trial period
Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
At Inclusion:
Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
Participation in another clinical trial before the first trial vaccination
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid 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
Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
History of seizures
Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
