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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00420316
First received: January 10, 2007
Last updated: October 4, 2012
Last verified: September 2012

January 10, 2007
October 4, 2012
February 2007
August 2007   (final data collection date for primary outcome measure)
Occurrence of any RV GE
Same as current
Complete list of historical versions of study NCT00420316 on ClinicalTrials.gov Archive Site
Occurrence of severe RV GE, severe GE, mortality and SAE (full study), mortality and IS (Retrospective)
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Rotavirus Gastroenteritis
Biological: Rotarix (primary vaccination study)
Other Name: Rotarix (primary vaccination study)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2601
Not Provided
August 2007   (final data collection date for primary outcome measure)

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.
Both
32 Months to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00420316
109810
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP