To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid
      buffer would be ideal for logistical, administrative and distribution ease, especially in
      routine immunization program.

        -  The advantages of the liquid vaccines are: Liquid vaccines take lesser time to
           administer compared to the current practice of giving antacid buffer prior to vaccine
           which takes 40% more time to administer.

        -  Easier to transport as it is stable at 2-80C compared to the frozen formulation that
           needs to be stored at -200C and transported in dry ice.

        -  Chances of human error during administration are lesser than the sequential
           administration of antacid and vaccine.
    

Detailed description: 
      Study Design and plan The study is designed as an adaptive, seamless sequential multicenter,
      single-blinded, randomized clinical trial with two phases: exploratory phase and confirmatory
      phase.

      Exploratory phase:

      1. Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of two different
      formulations of ROTAVAC 5C (BBIL-R2014-1 &BBILR2014-2) or ROTAVAC®. In this phase,
      immunogenicity and safety of the two new formulations will be compared with each other and
      with ROTAVAC® in the three treatment arms when administered at 4 weeks interval (+1week
      window). The first dose will be administered at 6-8 weeks of age. Each of the rotavirus
      vaccine formulations contains NLT 105fluorescent focus units (FFU)/Dose. After completion of
      the exploratory phase, analyses will be undertaken for selection of the most suitable
      formulation to undergo confirmatory phase of the study.

      Confirmatory Phase:

        1. Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of the selected
           formulation of ROTAVAC 5C (3 production lots) and ROTAVAC® to evaluate lot consistency.
           Additionally, non-interference with immune response to antigens contained in childhood
           vaccines will be evaluated.

        2. Active surveillance will be conducted for all participants for seven days after each
           dose of vaccine to ascertain information on solicited adverse events.("Reactogenicity")

        3. Surveillance for unsolicited AEs for all participants will be conducted from the time
           between first dose and 4-6 weeks after the 3rd dose.

      Surveillance for SAEs for all participants will be conducted from the time between first dose
      and 4-6 weeks after the 3rd dose
    

Intervention name(s): ROTAVAC®; ROTAVAC 5C -F1; ROTAVAC 5C -F2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer; ROTAVAC 5C formulation BBIL-R2014-1; ROTAVAC 5C formulation BBIL-R2014-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention