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.

NCT00480116 Phase 3 COMPLETED

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.

Details

Lead sponsor	Henogen
Phase	Phase 3
Status	COMPLETED
Enrolment	450
Start date	2008-01
Completion	2008-04

Conditions

• Hepatitis B

Interventions

• Adjuvanted Hepatitis B vaccine Lot 1
• Adjuvanted Hepatitis B vaccine Lot 2
• Adjuvanted Hep B vaccine Lot 3

Primary outcomes

• Anti-HBs seroprotection rates at Month 2. — Month 2

Countries

Czechia