Phase III Study of Liquid Formulation of ROTAVIN
Condition: Diarrhea; Diarrhea Rotavirus
MeSH terms: Diarrhea
Intervention: ROTAVIN (liquid formulation); ROTAVIN-M1 (frozen formulation)
Intervention description: Live attenuated human rotavirus vaccine containing ≥ 2x10^6 plaque forming units (PFU) of strain G1P[8] per dose of 2 mL.; Live attenuated human rotavirus vaccine containing ≥ 2x10^6 PFU of strain G1P[8] per dose of 2 mL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 825.0
Sex: All
Minimum age: 60 Days
Maximum age: 91 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ROTAVIN; Rotavirus vaccine; Rotavirus; Diarrhea

Summary:

      This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid
      formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine
      (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series
      starting at 2-3 months of age.

      The study will also assess the reactogenicity of the vaccine 7 days after each vaccination
      and safety from first vaccination up to 4 weeks after the last vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy infants as established by medical history and clinical examination before
             entering the study.

          2. Age: 60-91 days (both days inclusive) at the time of enrollment.

          3. Parental/legally acceptable representative ability and willingness to provide written
             informed consent.

          4. Parent/legally acceptable representative who intends to remain in the area with the
             child during the study period.

        Exclusion Criteria:

          1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment
             (temporary exclusion).

          2. Presence of fever on the day of enrollment (temporary exclusion).

          3. Acute disease at the time of enrollment (temporary exclusion).

          4. Concurrent participation in another clinical trial at any point throughout the entire
             time frame for this study.

          5. Presence of significant malnutrition (weight-for-height z-score < -3 SD median)

          6. Presence of any 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 participant's health or is likely to
             result in nonconformance to the protocol.

          7. History of congenital abdominal disorders, intussusception, or abdominal surgery.

          8. Known or suspected impairment of immunological function based on medical history and
             physical examination.

          9. Household contact with an immunosuppressed individual or pregnant woman.

         10. Prior receipt of rotavirus or an intent to receive this vaccine from outside of the
             study center during study participation.

         11. Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 days
             or plan to receive them within next 7 days.

         12. A known sensitivity or allergy to any components of the study vaccine.

         13. History of allergy to antibiotic kanamycin.

         14. Clinically detectable significant congenital or genetic defect.

         15. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).

         16. Receipt of immunoglobulin therapy and / or blood products since birth or planned
             administration during the study period.

         17. History of chronic administration (defined as more than 14 days) of immunosuppressants
             including corticosteroids. Infants on inhaled or topical steroids may be permitted to
             participate in the study.

         18. Any medical condition in the parent/legally acceptable representative or infant which,
             in the judgment of the Investigator, would interfere with or serves as a
             contraindication to protocol adherence.