EUCTR2011-004879-36-Outside-EU/EEA
Active, not recruiting
Not Applicable
Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA Hepatitis B vaccine (10µg) with or without Hepatitis B immunoglobulin (HBIG) in newborns of Hepatitis B envelope antigen positive (HBeAg+) mothers - HBV-302 EXT:HBV-143 Y15-Y20
ConditionsVaccination of healthy newborns of HBsAg+ and/or HBeAg+ mothers against Hepatitis.Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsEngerix™-B Junior
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaccination of healthy newborns of HBsAg+ and/or HBeAg+ mothers against Hepatitis.
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 69
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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