Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical consistency of three production lots of
      the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus
      (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to
      the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity,
      reactogenicity and safety when administered as a two-dose vaccination in healthy infants
      starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the
      study.
    

Detailed description: 
      -  Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled,
           multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).

        -  Duration of the study: The intended duration of the study, per subject, will be
           approximately 7-8 months including the 6 months of extended safety follow-up period
           after the last dose of HRV vaccine.

             -  Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up
                contact (Month 7-8).

        -  Primary completion Date (PCD): Visit 3 (Month 2-4).

        -  End of Study (EoS): Last testing results released of samples collected at Visit 3 or
           Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).

        -  Study Groups:

             -  PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)

             -  PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)

             -  PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)

             -  GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to
                as Lyo Group)

        -  Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine

        -  Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2
           month schedule according to the immunisation schedule for RV vaccine.

      Note that as a result of internal change in data standards terminology, the study data
      collected was converted to cDISC and the statistical analysis plan was amended accordingly.
      "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by
      "Day n+1". Thus, the time frames (Day 0, Day n) of Outcome Measures described in this study
      record are different to that denoted in the full protocol document posted.
    

Intervention name(s): HRV PCV-free liquid vaccine; Rotarix
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally; Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Healthy infants; Immunogenicity; Human Rotavirus (HRV)