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
Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
Able to attend all scheduled visits and to comply with all trial procedures.
You may not be if
Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
Chronic illness at a stage that could interfere with the conduct or completion of the trial
Blood or blood-derived products received since birth
HB vaccination since birth
Any vaccination in the four weeks preceding the first trial vaccination
Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
History of seizures
Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
