Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Condition: Infections, Rotavirus
MeSH terms: Hepatitis B; Rotavirus Infections
Intervention: Rotarix TM
Intervention description: Oral, 2 doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human rotavirus vaccine

Summary:

      The purpose of this study is to assess immunogenicity and safety of Rotarix TM when
      administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first
      vaccination) who received Hepatitis B immunoglobulin after birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 6 and 12 weeks of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent(s)/Legally Acceptable
             Representative(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Infants who have received a previous dose of hepatitis B immunoglobulin after birth.

        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 with the
             exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in
             the study area for the duration of the study.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of vaccine.

          -  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.

          -  Previous vaccination against rotavirus.

          -  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.

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins (with the exception of HBIG) and/or any blood
             products since birth or planned administration during the study period.

          -  Gastroenteritis within 7 days preceding the study vaccine administration.

          -  Previous confirmed occurrence of Rotavirus gastroenteritis.