drugset / Trial / NCT00224471

Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

NCT00224471

Phase 3 Completed 671 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

Summary

Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.

Timeline

Start
2003-12
Primary completion
2005-09
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK208141 Vaccine Intramuscular