Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

Phase 4

Completed

• Conditions: Hepatitis B Vaccine
• Interventions: Biological: Engerix™-B Kinder

• Registration Number: NCT00519649
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Study Start: 2007-08-31
• Primary Completion: 2007-12-31
• Study Completion: 2007-12-31
• Results First Submitted: 2008-12-17
• Results First Submitted QC: 2009-04-01
• Results First Posted: 2009-05-27
• Status Verified: 2016-11
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
• With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
• Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
• Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.
• History of or intercurrent hepatitis B disease.
• Hepatitis B vaccination at birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
• Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group Engerix	Engerix™-B Kinder	Subjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value	One month after the challenge dose of HBV vaccine	Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Solicited General Symptoms	During the 4-day follow-up period after the challenge dose of HBV vaccine.	Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
Number of Participants Reporting Serious Adverse Events (SAE)	After the challenge dose of HBV vaccine.	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Number of Participants Reporting Unsolicited Adverse Events	During the 31-day follow-up period after the challenge dose of HBV vaccine.	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value	Before challenge dose of HBV vaccine	Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
Number of Participants Reporting Solicited Local Symptoms	During the 4-day follow-up period after the challenge dose of HBV vaccine.	Solicited local symptoms assessed include pain, redness and swelling

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany