Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: Rotarix™; Placebo
Intervention description: Two or Three doses, oral administration; One or three doses, oral administration.
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)
Enrollment: 2089.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotavirus gastroenteritis; HRV vaccine

Summary:

      The primary objective of this study is to determine if the GSK Biologicals' human rotavirus
      (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on
      immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the
      20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV
      strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until
      Visit 5.

      The primary objective will be reached if the lower limit of the 95% confidence interval (CI)
      on vaccine efficacy is >0%.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female child between, and including, 5 and 10 weeks of age at the time of
             the first study vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject who is of
             legal age

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  In South Africa, birth weight > 2000 grams or if weight unknown, gestation period > 36
             weeks.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  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 product

          -  Planned administration of a vaccine not foreseen by the study protocol within 14 days
             before each dose of study vaccine(s) and ending 14 days after.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants since
             birth.

          -  History of use of experimental rotavirus vaccine.

          -  Previous routine vaccination except Bacille Calmette-Guérin (BCG), hepatitis B virus
             (HBV) and oral poliovirus (OPV) vaccination at birth

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the gastrointestinal tract, intussusception or
             other medical condition determined to be serious by the investigator.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  History of allergic disease or reaction likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  Gastroenteritis within 7 days preceding the first study vaccine administration

          -  Previous confirmed occurrence of rotavirus gastroenteritis (RV GE).

          -  A family history of congenital or hereditary immunodeficiency.

          -  Administration of immunoglobulins and/or blood products since birth or planned
             administration during the study period.

          -  History of any neurologic disorders or seizures.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.