Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

Phase 4

Completed

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

• Registration Number: NCT00411697
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-13
• Study First Submitted QC: 2006-12-13
• Study First Posted: 2006-12-14
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

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 4 to 5 years of age at the time of enrolment.
• With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ 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.

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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 fourth dose of Infanrix hexa™ booster in the second year of life.
• 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 booster vaccination and ending 30 days after.
• Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Engerix™-B Kinder	-

Primary Outcome Measures

Name	Time	Method
Anti-hepatitis B surface antigen (HBs) antibody concentrations	One month after the challenge dose of HBV vaccine

Secondary Outcome Measures

Name	Time	Method
Anti-HBs antibody concentrations	Before and after challenge dose of HBV vaccine
Occurrence of serious adverse events	During the entire study period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Berlin, Germany