A Phase 3 interventional study of 2-dose oral live attenuated G1P[8] human rotavirus vaccine in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed at 12 sites in Finland. Open to participants aged 11 Weeks to 17 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.
101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 1,200 is above the median of 402 across 68 interventional studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline