Last updated: 11/03/2018 10:37:39

Long-term efficacy and safety of subjects approximately 3 years after priming with 2 doses of GSK Bio’s HRV vaccine.

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GSK study ID
109810
See study documents
Clinicaltrials.gov ID
NCT00420316
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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).
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with any rotavirus gastroenteritis (RVGE)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Secondary outcomes:

Number of subjects with severe rotavirus gastroenteritis (RVGE)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects with severe gastroenteritis (GE)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Number of subjects reporting intussusception (IS)

Timeframe: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)

Interventions:
Biological/vaccine: Rotarix (primary vaccination study)
Biological/vaccine: Placebo (primary vaccination study)
Enrollment:
1613
Observational study model:
Not applicable
Primary completion date:
2007-08-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
February 2007 to August 2007
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
32 months - 3 years
Accepts healthy volunteers
Yes
  • Inclusion Criteria:
  • A male or female who has completed the second year
Inclusion and exclusion criteria
Inclusion criteria:
  • 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.

Trial location(s)

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

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2007-08-08
Actual study completion date
2007-08-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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