Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine; Lyophilized formulation of GSK's oral live attenuated HRV vaccine
Intervention description: 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.; 2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Data were collected in an observer-blind manner. By observer-blind, it is meant that during the study period, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were all unaware of which vaccine was administered.
Enrollment: 1351.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HRV; Lyophilized formulation; Liquid formulation; Human rotavirus vaccine; Rotarix; Healthy infants; PCV-free; Porcine circovirus-free

Summary:

      The purpose of this study is to complete the total safety database size for GlaxoSmithKline
      Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free
      development plan.

      This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper
      range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored
      frozen in order to keep the titer stable until administration during the study.

      As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized
      formulation of the vaccine was used as a control in all phase III studies as part of the
      PCV-free development plan.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy all the following criteria at study entry:

          -  Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will
             comply, with the requirements of the protocol (e.g. completion of the diary cards,
             return for follow-up visits).

          -  Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s)
             of the subject prior to performance of any study specific procedure.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the
             time of the first vaccination.

        Exclusion Criteria:

        Medical conditions

          -  Uncorrected congenital malformation (such as Meckel's diverticulum) of the
             gastrointestinal tract that would predispose for Intussusception (IS).

          -  Very prematurely born infants (born ≤28 weeks of gestation).

          -  History of IS.

          -  Family history of congenital or hereditary immunodeficiency.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Hypersensitivity to latex.

          -  Major congenital defects or serious chronic illness, as assessed by the investigator.

          -  Previous confirmed occurrence of Rotavirus Gastroenteritis (RV GE).

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  History of Severe combined immunodeficiency (SCID). Prior/Concomitant therapy

          -  Use of any investigational or non-registered product (drug, vaccine or medical device)
             other than the study vaccines during the period starting 30 days before the first dose
             of study vaccines (Day -29 to Day 1), or planned use during the study period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose and ending 30 days after the last
             dose of study vaccine administration, with the exception of the inactivated influenza
             vaccine, which is allowed at any time during the study, and other licensed routine
             childhood vaccinations.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

          -  Administration of immunoglobulins and/or any blood products from birth or planned
             administration during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs since birth. For corticosteroids, this will mean
             prednisone ≥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Previous vaccination against RV. Prior/Concurrent clinical study experience

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product (drug or medical device).

        Other exclusions

        • Child in care.