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Twinrix Adult Vaccination Schedules
NCT00216229Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2004
- Countries
- 1
- Sponsor
- IDEWE
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- hepatitis A (HAV)hepatitis B (HBV)
01
Overview
Phase 4, randomised, open-label trial of hepatitis b vaccine recombinant in hepatitis A (HAV) and hepatitis B (HBV) (2 arms), sponsored by IDEWE. Primary endpoint: Anti-HBs antibodies concentration. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Schedule 0-1-12
Twinrix administered at 0, 1, and 12 months
Schedule 0-1-6
Twinrix administered at 0, 1, and 6 months
03
Who it enrols
Healthy adults 18 years or older in good physical condition. Excludes employees occupationally exposed to hepatitis B virus.
04
Endpoints
Primary
Anti-HBs antibodies concentration
Secondary
Seroconversion rate (>= 1 IU/l)
Seroprotection rate (>= 10 IU/l)
Distribution of anti-HBs
Natural evolution of anti-HBs antibodies concentration
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