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–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Two months old infants on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Informed consent form signed by one or both parents or by the guardian and two independent witnesses
Able to attend all scheduled visits and to comply with all trial procedures
Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
You may not be if
Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency
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 since birth
Any vaccination in the four weeks preceding the first trial visit
Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of seizures
Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
