A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children
Condition: Adverse Event Following Immunisation
Intervention: SABIN monovalent OPV2
Intervention description: SABIN monovalent OPV2 is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE
      recommendations at the time of writing this protocol. After this cessation of OPV2,
      stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future
      outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population
      immunity. Research is ongoing to develop vaccines that are genetically more stable than the
      currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and
      genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio
      vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is
      performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability
      endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of
      aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine,
      and for comparison with any potential new polio vaccine with a type 2 component in the
      future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged 1 to 5 years previously vaccinated with three or four doses of IPV
             (Group 1) or unvaccinated infants aged 6 weeks (-7 to +14 days) (Groups 2 and 3).

          2. For Groups 2 and 3 (enrolled at 6 weeks of age) infants must have been vaccinated with
             3 doses of bOPV and one dose of IPV prior to administration of the study vaccine, and
             the last Polio vaccine must have been administered at least 4 weeks prior to the study
             vaccine.

          3. Healthy without obvious medical conditions that preclude the subject to be in the
             study as established by the medical history and physical examination.

          4. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per
             country regulations.

        Exclusion Criteria:

          1. For Group 1: polio vaccines within the 3 months prior to the administration of the
             study vaccine (number of previous polio vaccine doses to be documented). For Groups 2
             and 3: polio vaccines prior to administration of the study vaccine other than 3 doses
             of bOPV and 1 dose of IPV .

          2. Any confirmed or suspected immunosuppressive or known immunodeficient condition
             including human immunodeficiency virus (HIV) infection.

          3. Family history of congenital or hereditary immunodeficiency.

          4. Major congenital defects or serious uncontrolled chronic illness (neurologic,
             pulmonary, gastrointestinal, hepatic, renal, or endocrine).

          5. Known allergy to any component of the study vaccines or to any antibiotics.

          6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections
             (of IPV).

          7. Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          8. 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.).

          9. Member of the subject's household (living in the same house or apartment unit) has
             received OPV in the last 3 months.

         10. 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.