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).
1 other identifier
interventional
1,613
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedStudy Start
First participant enrolled
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2007
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedAugust 28, 2018
July 1, 2018
6 months
January 10, 2007
January 5, 2017
July 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)
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
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
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
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
During the study period for the long-term follow-up (i.e. 6 months)
- +3 more secondary outcomes
Study Arms (2)
Rotarix Group
EXPERIMENTALHealthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarixâ„¢ 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.
Placebo Group
PLACEBO COMPARATORHealthy 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.
Interventions
GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Espoo, 02100, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kotka, 48600, Finland
GSK Investigational Site
Kuopio, 70100, Finland
GSK Investigational Site
Lahti, 15140, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Pori, 28120, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vantaa, 01300, Finland
GSK Investigational Site
Vantaa, 01600, Finland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 11, 2007
Study Start
February 12, 2007
Primary Completion
August 8, 2007
Study Completion
August 8, 2007
Last Updated
August 28, 2018
Results First Posted
February 23, 2017
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.