ong term follow up (LTFU) study 16-20 yrs after hepatitis B vaccination in newborns of mothers who were seropositive for Hepatitis B envelope antigen (HBeAg) and Hepatitis B surface antigen (HBsAg)

Conditions: Hepatitis B vaccination in healthy newborns of HBeAg+ and HBsAg+ mothers
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-002629-23-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 36

Inclusion Criteria

The subjects should have participated in the primary study.
Written informed consent was taken from the subject and the subject’s parents or guardians at the first long-term time-point between Year 16 and Year 20.

Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
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
Main Objective: To evaluate the anti-HBs persistence up to Year 20 after the first vaccine dose of the primary vaccination.<br>To evaluate the prevalence and incidence of other Hepatitis B markers (HBsAg, anti-bodies to Hepatitis B core antigen [anti-HBc], HBeAg, antibodies to Hepatitis B envelope antigen [anti-HBe]) up to Year 20 after the first vaccine dose of the primary vaccination.<br>To evaluate the clinical significance of the HBsAg+ and anti-HBc+ cases observed during the long-term follow-up (LTFU) of this study.<br>;Secondary Objective: Not applicable;Primary end point(s): The anti-HBs seropositivity rate, seroprotection rate and Geometric Mean Titre (GMT) <br>The prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe).<br>A case by case review of the clinical significance of the HBsAg positive and anti-HBc positive cases observed during the long-term follow-up of this study.;Timepoint(s) of evaluation of this end point: At Years 16, 17, 18, 19 and 20.

Secondary Outcome Measures