NCT00480116

Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Henogen · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.

Detailed description

Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted Hepatitis B vaccine Lot 1	20 µg, IM, month 0 and 1
BIOLOGICAL	Adjuvanted Hepatitis B vaccine Lot 2	20µg, IM, month 0 and 1
BIOLOGICAL	Adjuvanted Hep B vaccine Lot 3	20µg, IM, month 0 and 1

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-05-30
• Last updated: 2008-08-25

Locations

1 site across 1 country: Czechia