NCT00969228

Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 684 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.

Conditions

• Infections, Rotavirus
• Rotavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix ™	Two oral doses
BIOLOGICAL	Placebo	Two oral doses

Timeline

• Start date: 2009-08-25
• Primary completion: 2010-07-23
• Completion: 2010-07-23
• First posted: 2009-09-01
• Last updated: 2020-01-18
• Results posted: 2011-11-28

Locations

18 sites across 1 country: South Korea