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

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).

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 Overview

• Status: Completed
• Conditions: Infections, Rotavirus
• Intervention / Treatment: Biological: Rotarix (primary vaccination study); Biological: Placebo (primary vaccination study)

• Study Type: Interventional
• Enrollment (Actual): 1613
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02100
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Kotka, Finland, 48600
    • GSK Investigational Site
  • Kuopio, Finland, 70100
    • GSK Investigational Site
  • Lahti, Finland, 15140
    • GSK Investigational Site
  • Oulu, Finland, 90100
    • GSK Investigational Site
  • Pori, Finland, 28120
    • GSK Investigational Site
  • Seinajoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Tampere, Finland, 33520
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
  • Vantaa, Finland, 01300
    • GSK Investigational Site
  • Vantaa, Finland, 01600
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotarix Group; 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); GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
Placebo Comparator: Placebo Group; 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); Two liquid oral doses of placebo

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2007
• Primary Completion (Actual): August 8, 2007
• Study Completion (Actual): August 8, 2007

Study Registration Dates

• First Submitted: January 10, 2007
• First Submitted That Met QC Criteria: January 10, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Gastroenteritis; Finland; Intussusception
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: 109810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 109810
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register