Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: GSK Biologicals' liquid human rotavirus vaccine 444563; Placebo; Infanrix™; Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Intervention description: Oral administration; Oral administration; Intramuscular administration; 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: 3340.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liquid human retrovirus vaccine

Summary:

      The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK
      Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/Legally Acceptable
             Representatives can and will comply with the requirements of the protocol.

          -  A male or female infant of Chinese origin between, and including, 6 and 16 weeks of
             age at the time of the first vaccination.

          -  Written informed consent obtained from the parents/Legally Acceptable Representatives
             of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/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 the first
             dose of the human rotavirus vaccine or placebo except for the routine childhood
             vaccinations.

          -  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.

          -  Any clinically significant history of gastrointestinal disease including any
             uncorrected congenital malformation (such as Meckel's diverticulum) of the
             gastrointestinal tract that would predispose for intussusception .

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of confirmed rotavirus gastroenteritis.

          -  Acute disease and/or fever at the time of enrolment.

          -  Gastroenteritis within 7 days preceding the study vaccine or placebo administration.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

        In addition to the criteria mentioned above, the following criteria will be applicable to
        all subjects in the immunogenicity subgroup 2:

          -  History of diphtheria, tetanus and pertussis disease.

          -  History of seizures or progressive neurological disease.

          -  Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.