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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:
ClinicalTrials.gov Identifier:
NCT00420316
First Posted: January 11, 2007
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
January 10, 2007
January 11, 2007
January 5, 2017
February 23, 2017
February 23, 2017
February 2007
August 2007   (Final data collection date for primary outcome measure)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
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.
Occurrence of any RV GE
Complete list of historical versions of study NCT00420316 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects With Severe Gastroenteritis (GE) [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]
    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.
  • Number of Subjects Reporting Intussusception (IS) [ Time Frame: During the period starting from the end of the second follow-up up to the start of the study (end of July 2006 to beginning of January 2007) ]
    Intussusception is defined as the telescoping of the intestine.
Occurrence of severe RV GE, severe GE, mortality and SAE (full study), mortality and IS (Retrospective)
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections, Rotavirus
  • Biological: Rotarix (primary vaccination study)
    GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
  • Biological: Placebo (primary vaccination study)
    Two liquid oral doses of placebo
  • 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.
    Intervention: Biological: Rotarix (primary vaccination study)
  • 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.
    Intervention: Biological: Placebo (primary vaccination study)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2601
August 2007
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.
Sexes Eligible for Study: All
32 Months to 3 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00420316
109810
Not Provided
Not Provided
Plan to Share IPD: Yes
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2017

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