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

Infections, Rotavirus Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420316
• Other study ID #: 109810
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

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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