Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1; BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2; BioFarma Bivalent Oral Poliomyelitis Vaccine
Intervention description: Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 cell culture infectious dose 50% (CCID50)/dose and 10^5.8 CCID50/dose, respectively.; Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10^6 CCID50/dose and 10^5.8 CCID50/dose, respectively.; Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 and 10^5.8 infective units per dose, respectively.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 750.0
Sex: All
Minimum age: 1 Day
Maximum age: 14 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV)
      manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar
      immunogenicity profile to a WHO prequalified bOPV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, full-term infants, as established by medical history and clinical examination
             before entering into the study.

          -  Parents willing to provide written informed consent.

          -  Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through
             the 14th day of life, inclusive)

        Exclusion Criteria:

          -  Birth weight (as documented at first medical contact) less than 2.5 kg

          -  Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment
             (temporary exclusion)

          -  Presence of fever (> 37.5°C) on the day of enrollment (temporary exclusion)

          -  Acute disease at the time of enrollment (temporary exclusion)

          -  Significant malnutrition as per Investigator's judgment

          -  Concurrent participation in another clinical study at any time during the study period
             in which the infant will be exposed to an investigational or a non-investigational
             product

          -  Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic,
             renal, gastrointestinal, hematological, endocrine, immunological, dermatological,
             neurological, cancer or autoimmune disease) as determined by medical history and/or
             physical examination which would compromise the child's health or is likely to result
             in non-conformance to the protocol

          -  Known or suspected impairment of immunological function (including human
             immunodeficiency virus [HIV] exposure) based on medical history and physical
             examination

          -  Previous receipt of polio virus vaccine

          -  Household contact with a known immunosuppressed individual

          -  Unwillingness or inability of parents for active follow-up by the study staff

          -  History of any neurological disorders or seizures

          -  Any medical condition that, in the judgment of the investigator, would interfere with
             or serve as a contraindication to protocol adherence or a participant's ability to
             give informed consent

          -  Maternal HIV infection