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
Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator
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
Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 (except BCG) in the 4 weeks preceding the first trial vaccination
Vaccination planned in the 4 weeks following trial vaccination
History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of seizures
Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.