Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

• Serum Anti-rotavirus IgA Antibody Concentrations. [ Time Frame: 2 months post-Dose 2 (at study Month 4) ] [ Designated as safety issue: No ]
  Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
• Number of Subjects Reporting Solicited General Symptoms. [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ] [ Designated as safety issue: No ]
  Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.
• Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. [ Time Frame: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) ] [ Designated as safety issue: No ]

  RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.

  GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).

• Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow-up period after vaccination ] [ Designated as safety issue: No ]
  An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
• Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (from Dose 1 at Day 0 up to Month 4) ] [ Designated as safety issue: No ]
  SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

• Immunogenicity to study vaccine antigen [ Time Frame: Two months after the second vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of each type of solicited symptom [ Time Frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
• Occurrence of unsolicited adverse event [ Time Frame: Within the 31-day (Day 0 - Day 30) follow-up period after any vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events [ Time Frame: Throughout the study period (Day 0 up to Month 4) ] [ Designated as safety issue: No ]
• Presence of rotavirus in gastroenteritis stool samples. [ Time Frame: From Dose 1 (Day 0) up to study end (Month 4). ] [ Designated as safety issue: No ]

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.

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.