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
The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.
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
Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum
Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
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 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known 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 (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
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 during the trial (until Visit 06), except the study vaccines, rotavirus vaccine and pneumococcal conjugate vaccines
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically)
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s)
Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity
Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
History of seizures
Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
