To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

• Number of Subjects Reporting Solicited Symptoms [ Time Frame: During 15 days after each vaccine dose ] [ Designated as safety issue: No ]
  Solicited symptoms assessed include cough, diarrhea, fever, irritability, loss of appetite and vomiting.
• Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During 31 days after each vaccine dose ] [ Designated as safety issue: No ]
  Unsolicited Adverse event (AE) covers any AE 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 (SAE) [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  An SAE is any untoward medical occurrence that : results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.

The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.

Filipino subjects aged at least 6 weeks at the time of first vaccination

• Biological: Rotarix
  Two doses of the oral vaccine
• Other: Data collection
  Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
• Any contraindications as stated in the Prescribing Information.