To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.

Time frame: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.

Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

Time frame: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.

Assessed solicited general symptoms were cough/runny nose, diarrhea, fever \[defined as rectal temperature equal to or above 38 degrees Celsius (°C)\], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.

The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.

Time frame: From the first vaccine dose (Dose 1) up to Month 4

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: Throughout the entire study period (from Day 0 to Month 4)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.

Time frame: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4.