Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
- Conditions
- Infections, Rotavirus
- Interventions
- Biological: Placebo (primary vaccination study)Biological: Rotarix (primary vaccination study)
- Registration Number
- NCT00420316
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1613
- A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- Written informed consent obtained from the parent or guardian of the subject.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo (primary vaccination study) Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. Rotarix Group Rotarix (primary vaccination study) Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
- Primary Outcome Measures
Name Time Method Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) During the study period for the long-term follow-up (i.e. 6 months) 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.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) During the study period for the long-term follow-up (i.e. 6 months) 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.
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype During the study period for the long-term follow-up (i.e. 6 months) 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.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the study period for the long-term follow-up (i.e. 6 months) 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.
Number of Subjects With Severe Gastroenteritis (GE) During the study period for the long-term follow-up (i.e. 6 months) Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.
Number of Subjects Reporting Intussusception (IS) During the period starting from the end of the second follow-up up to the start of the study (up to 6 months) Intussusception is defined as the telescoping of the intestine.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype During the study period for the long-term follow-up (i.e. 6 months) 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.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype During the study period for the long-term follow-up (i.e. 6 months) 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.
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype During the study period for the long-term follow-up (i.e. 6 months) 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇫🇮Vantaa, Finland