NCT00224471

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

A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 10 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
BIOLOGICAL	GSK208141 vaccine	3 IM doses

Timeline

• Start date: 2003-12-01
• Primary completion: 2005-09-01
• Completion: 2006-01-01
• First posted: 2005-09-23
• Last updated: 2016-09-21

Locations

13 sites across 3 countries: United States, Belgium, Canada