Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

Inclusion criteria

• Age: 6 weeks (-7 to +14 days).
• Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
• Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.

Exclusion criteria

• Previous vaccination against poliovirus.
• Low birth weight (BW <2,500 gm).
• Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
• Family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
• Known allergy to any component of the study vaccines.
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
• Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
• Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.