The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,351
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Frederick, Maryland, United States
GSK Investigational Site
Fall River, Massachusetts, United States
Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Time frame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Time frame: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Number of Subjects With Any Unsolicited AEs
An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Time frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
Number of Subjects With Any Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: Throughout the study period (from Day 1 up to Month 7 or Month 8)
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GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
East Orange, New Jersey, United States
...and 27 more locations