To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,613
GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
Two liquid oral doses of placebo
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Helsinki, Finland
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
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GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kotka, Finland
GSK Investigational Site
Kuopio, Finland
GSK Investigational Site
Lahti, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Pori, Finland
GSK Investigational Site
Seinäjoki, Finland
...and 5 more locations
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Gastroenteritis (GE)
Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Intussusception (IS)
Intussusception is defined as the telescoping of the intestine.
Time frame: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)