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
2 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 legally acceptable representative and 1 or 2 independent witnesses
Able to attend all scheduled visits and to comply with all trial procedures
Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
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 corticosteroids therapy
Subjects with congenital or acquired immunodeficiency in the child's surrounding
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 4 weeks preceding the first trial vaccination
Vaccination planned in the 4 weeks following the trial vaccination
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
History of seizures
Febrile or acute illness on the day of inclusion.
Clareo Health | Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
