Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

This is an interventional prevention trial for Infections, Rotavirus Read More

Inclusion Criteria:

• Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
• Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
• History of allergic disease
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
• Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
• Previous confirmed occurrence of RV GE.
• Household contact with an immunosuppressed individual or pregnant women.
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period