Change in Manufacture Process of Heberbiovac HB vaccine.
Phase 2
- Conditions
- Viral hepatitis type B.
- Registration Number
- RPCEC00000105
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB).
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
1) Healthy apparent subjects from both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age. 4) Signing of the written inform consent sheet.
Exclusion Criteria
1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg. 3) Underlying immunosuppressive disease, intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases. 5) Feverish states (>37.5°C) at the momento of vaccination. 6) History of severe allergy. 7) History of allergy to any component of the vaccine or to thiomersal. 8) Pregnancy or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprotection percentage (+ de 10 UI of AntiHBs antibodies). Measuring time: 90 days after the administration of the first vaccine dose. Hyper-responder rate (+ de 1000 UI, Yes/No). Measuring time: 90 days after the administration of the first vaccine dose. antiHBs GMT. Measuring time: 90 days after the administration of the first vaccine dose
- Secondary Outcome Measures
Name Time Method ocal and systemic adverse events, within 72 hours, and at 7 and 30 days after vaccination in each dose.