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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00420316
Other study ID # 109810
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 12, 2007
Est. completion date August 8, 2007

Study information

Verified date July 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1613
Est. completion date August 8, 2007
Est. primary completion date August 8, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 32 Months to 3 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Rotarix (primary vaccination study)
GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
Placebo (primary vaccination study)
Two liquid oral doses of placebo

Locations

Country Name City State
Finland GSK Investigational Site Espoo
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Jarvenpaa
Finland GSK Investigational Site Kotka
Finland GSK Investigational Site Kuopio
Finland GSK Investigational Site Lahti
Finland GSK Investigational Site Oulu
Finland GSK Investigational Site Pori
Finland GSK Investigational Site Seinajoki
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
Finland GSK Investigational Site Vantaa
Finland GSK Investigational Site Vantaa

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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