NCT00420316

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,613 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 32 Months – 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix (primary vaccination study)	GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
BIOLOGICAL	Placebo (primary vaccination study)	Two liquid oral doses of placebo

Timeline

• Start date: 2007-02-12
• Primary completion: 2007-08-08
• Completion: 2007-08-08
• First posted: 2007-01-11
• Last updated: 2018-08-28
• Results posted: 2017-02-23

Locations

15 sites across 1 country: Finland