drugset / Trial / NCT00363545

To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

NCT00363545

Phase 3 Completed 1274 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine

Timeline

Start
2006-09-01
Primary completion
2007-04-12
Completion
2007-04-12

Publications

  • Background Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotarix Vaccine Oral

Indications