A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: Rotarix; Placebo; Tritanrix-HB+Hib; Polio Sabin
Intervention description: Oral vaccination; Oral administration; Concomitant routine vaccination, IM administration; Oral administration, concomitant routine vaccination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study was conducted in a double-blind manner. The parents/guardians of the subjects and the study personnel were unaware of the administered treatment (HRV vaccine or placebo).
Enrollment: 100.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: No

Summary:

      The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK
      Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines
      including OPV in HIV positive infants. 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 between, and including 6 and 10 weeks of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the parents or guardians of the subject

          -  Documented HIV status of the subject as confirmed by PCR.

          -  HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to
             WHO's most recent classification for HIV stages in infants and children.

          -  Born after a gestation period of 36 to 42 weeks.

        Exclusion Criteria:

          -  Use of any investigational or non-registered 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.

          -  Previous routine vaccination except OPV, BCG and HBV vaccination at birth

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the GI tract or other serious medical condition
             as determined by the investigator.

          -  History of allergic disease or reaction likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at time of enrolment.

          -  Gastroenteritis within 7 days preceding the study vaccine administration.

          -  Previous confirmed occurrence of RV gastroenteritis.

          -  Other conditions which in the opinion of the investigator may potentially interfere
             with interpretation of study outcomes.

          -  HIV moderately and severely symptomatic: stages III and IV according to WHO's recent
             classification.

          -  Administration of immunoglobulins and/or blood products since birth or planned
             administration during the study period.