A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: Oral Polio Vaccine
Intervention description: Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment.
The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe
      adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5
      year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity
      (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in
      vaccine-naïve infants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age:

             Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group
             2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.

          2. Healthy without obvious medical conditions that preclude the subject to be in the
             study as established by the medical history and physical examination.

          3. Written informed consent obtained from 1 or 2 parents or legal guardians as per
             Dominican Republic regulations.

        Exclusion Criteria:

          1. Previous Vaccinations:

             Group 1: Previous vaccination against poliovirus outside of the national immunization
             schedule and any vaccine in the previous 4 weeks.

             Group 2: Any vaccination against poliovirus

          2. Group 2: Infants with birth weight (BW) < 2,500 gm.

          3. Any confirmed or suspected immunosuppressive or known immunodeficient condition
             including human immunodeficiency virus (HIV) infection.

          4. Family history of congenital or hereditary immunodeficiency.

          5. Major congenital defects or serious uncontrolled chronic illness (neurologic,
             pulmonary, gastrointestinal, hepatic, renal, or endocrine).

          6. Known allergy to any component of the study vaccines or to any antibiotics.

          7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.

          8. Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          9. 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).

         10. Member of the subject's household (living in the same house or apartment unit) has
             received OPV in the last 3 months, or is scheduled to receive OPV during the study
             period.

         11. 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.