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

Study Overview
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Brief Summary
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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.

Official Title
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To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: Rotarix (primary vaccination study)
* Biological: Placebo (primary vaccination study)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 32 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotarix Group<br>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. | Biological: Rotarix (primary vaccination study)<br>* GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.<br>|
| Placebo Comparator: Placebo Group<br>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. | Biological: Placebo (primary vaccination study)<br>* Two liquid oral doses of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the study period for the long-term follow-up (i.e. 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | During the period starting from the end of the second follow-up up to the start of the study (up to 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intussusception, Gastroenteritis, Finland