Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

Phase 3

Completed

• Conditions: Infections, Rotavirus

• 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

Study Timeline

• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Study Start: 2007-02-12
• Primary Completion: 2007-08-08
• Study Completion: 2007-08-08
• Results First Submitted: 2017-01-05
• Results First Submitted QC: 2017-01-05
• Results First Posted: 2017-02-23
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1613

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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