Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
- Conditions
- Hepatitis B
- Registration Number
- NCT00291954
- Lead Sponsor
- Henogen
- Brief Summary
Hepatitis B prevention in non-responders uraemic patients is currently based on both HBsAg surveillance and the isolation from HBsAg carriers. A more immunogenic vaccine would be a benefit for this population.
- Detailed Description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis Pasteur's hepatitis B vaccine. The study involves a total of 4 visits and blood samples will taken at each of these visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-HBs seroprotection rate Month 2
- Secondary Outcome Measures
Name Time Method Percentage of subjects with anti-HBs antibody concentrations superior or equal to 100 mIU/ml for all subjects Months 0, 1 and 2 Occurrence and intensity of solicited local signs and symptoms, relationship to vaccination of solicited general signs and symptoms reported during the 4-day follow-up period after each vaccination and overall Month 0, 1 and 2 Anti-HBs Seroprotection rates for all subjects. Months 0, 1 and 2 Anti-HBs Geometric Mean Concentrations calculated for all subjects. Months 0, 1 and 2 Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall Month 0, 1 and 2 Anti-HBs Seropositivity rates for all subjects. Months 0, 1 and 2 Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2 Month 0 to 2
Trial Locations
- Locations (25)
O.L.Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium
RHMS La Madeleine ATH
🇧🇪ATH, Belgium
RHMS Clinique Louis Caty Baudour
🇧🇪Baudour, Belgium
Cliniques universitaires Saint Luc
🇧🇪Bruxelles, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
🇧🇪Bruxelles, Belgium
ULB Hôpital Erasme Département de Néphrologie
🇧🇪Bruxelles, Belgium
CHU Hôpital civil de
🇧🇪Charleroi, Belgium
UZ AntwerpenDienst nefrologie
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
CHU Tivoli
🇧🇪La Louvière, Belgium
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