A phase IIIb open study to assess the long-term efficacy and safety of GlaxoSmithKline (GSK) Biologicals' oral live attenuated human rotavirus (HRV) vaccine approximately three years after vaccination in healthy infants aged 6-12 weeks at the time of first vaccination in the Rota-036 study (102247) in Finland. - ROTA-036 EXT Y3
Phase 1
- Conditions
- ong-term efficacy and safety follow-up
- Registration Number
- EUCTR2006-006552-36-FI
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1613
Inclusion Criteria
•A male or female who has completed the second year efficacy follow-up of the primary vaccination study (Rota-036, eTrack No.102247) in Finland.
•Written informed consent obtained from the parent or guardian of the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not applicable as this study is a long-term efficacy and safety follow-up of subjects who have received the HRV vaccine or the placebo dose in the primary vaccination study (Rota-036).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To assess the efficacy of GSK Biologicals’ HRV vaccine with respect to any RV GE episodes caused by the circulating wild-type RV strains during the follow-up period.;Secondary Objective: Secondary efficacy objectives, to assess:<br>•efficacy of GSK's HRV vaccine with respect to severe RV GE caused by circulating wild-type RV strains<br>•if administration of GSK's HRV vaccine can prevent any & severe RV GE caused by wild-type RV strain of G1 and non-G1 serotypes<br>•if administration of GSK's HRV vaccine can prevent severe GE<br>Secondary safety objectives:<br>•safety of GSK's HRV vaccine in terms of mortality & occurrence of SAEs during the follow-up period<br>•safety of GSK's HRV vaccine in terms of mortality & occurrence of IS during the period from end of the 2nd follow-up period up to the start of the study (retrospective follow-up);Primary end point(s): •Occurrence of any RV GE caused by the circulating wild-type RV strains during the study period for the long-term follow-up.
- Secondary Outcome Measures
Name Time Method