Influence of time of vaccination on Hepatitis B vaccine responses in health care students
Phase 1
- Conditions
- The immune response to Hepatitis B vaccine is being investigated.MedDRA version: 20.1 Level: PT Classification code 10019732 Term: Hepatitis B antibody System Organ Class: 10022891 - InvestigationsMedDRA version: 20.0 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-003756-32-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Age more than or equal to16 years.
University student in good health who consents to fill diary cards, provide saliva and blood samples and is able to attend a morning/afternoon/evening vaccination session
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- History of HepB infection or vaccination
- Immunosuppression including HIV or chronic/current steroid use
- Receipt of blood products or IgG within 3 months of enrolment
- Any contraindication to Hepatitis B vaccination per Green Book
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method