ong Term Follow-up (LTFU) study 16-20 yrs after vaccine dose of hepatitis b with/without Hepatitis B immunoglobulin (HBIG) in newborns to Hepatitis B envelope antigen positive (HBeAg+) mothers.
- Conditions
- Vaccination of healthy newborns of HBsAg+ and/or HBeAg+ mothers against Hepatitis.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004879-36-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
Subjects who participated in the primary study and were interested in participating in a follow-up study.
Written informed consent was obtained from the subjects or subject’s parents/LAR at each of the annual time-points.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not applicable
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