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 infant (50 to 71 days old) on the day of inclusion, of either gender.
Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg.
Hepatitis B vaccination since birth.
Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative 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.
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.
Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
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 4 weeks preceding the first trial vaccination.
Any planned vaccination (except trial vaccinations) during the trial.
Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
History of seizures.
Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.
