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Long 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)

Immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-Hepatitis B vaccine (10 µg) in newborns of Hepa-titis B envelope antigen positive (HBeAg+) and Hepatitis B surface antigen positive (HBsAg+) mothers compared with a historical control group. - HBV-301 EXT: HBV-115 Y16-Y20

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002629-23-Outside-EU/EEA
Enrollment
36
Registered
2015-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B vaccination in healthy newborns of HBeAg+ and HBsAg+ mothers

Interventions

Trade Name: Engerix™-B Junior Product Name: Engerix™-B Junior Product Code: HBV Paediatric 10 Pharmaceutical Form: Suspension for injection INN or Proposed INN: - Current Sponsor code: HBsAg Other des

Sponsors

GlaxoSmithKline Biologicals
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the anti-HBs persistence up to Year 20 after the first vaccine dose of the primary vaccination. 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. To evaluate the clinical significance of the HBsAg+ and anti-HBc+ cases observed during the long-term follow-up (LTFU) of this study. ;Secondary Objective: Not applicable;Primary end point(s): The anti-HBs seropositivity rate, seroprotection rate and Geometric Mean Titre (GMT) The prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe). 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

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not aplicable—

Countries

Thailand

Contacts

Public ContactClinical Disclosure Advisor

GlaxoSmithKline Biologicals

GSKClinicalSupportHD@gsk.com442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026