Clinical trial NCT00420316: Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: Intussusception
Gastroenteritis
Finland
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 1613
Sex: ALL
Minimum age (years): 32
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)
timeFrame: During the study period for the long-term follow-up (i.e. 6 months)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Number of Subjects With Severe Gastroenteritis (GE)
timeFrame: During the study period for the long-term follow-up (i.e. 6 months)
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the study period for the long-term follow-up (i.e. 6 months)
measure: 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)
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kotka
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Lahti
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: