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Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Engerix™-B (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.

Clinical Details

Official title: Immune Response to a Hepatitis B Vaccine Challenge Dose in Healthy Subjects Who Received Primary Vaccination of GlaxoSmithKline Biologicals' Hepatitis B Vaccine, Approximately 20 Years Ago.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine

Secondary outcome:

Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values

Concentration of Anti-HBs Antibodies

Number of Subjects Reporting Unsolicited Adverse Events

Number of Subjects Reporting Serious Adverse Events


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the

requirements of the protocol should be enrolled in the study.

- A male or female adult who received the complete neonatal primary vaccination course

of hepatitis B vaccine (Engerix™-B), in the 103860/272 primary study approximately 20 years earlier.

- Documented level of anti-HBs antibody concentrations < 100 milli-international units

per milliliter (mIU/ml) at the previous long-term time-point for which serological results are available for that subject.

- Written informed consent obtained from the subject.

- Healthy subjects as established by medical history and clinical examination before

entering into the study.

- If the subject is female, she must be of non-childbearing potential or if she is of

childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis B challenge dose. Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the

study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use 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 hepatitis B vaccine challenge dose.

- Planned administration/ administration of a vaccine not foreseen by the study

protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.

- Subjects who received a booster dose of hepatitis B vaccine outside the context of

this study between the long-term time-point at the documented level of anti-HBs antibody concentrations and the current challenge dose study visit.

- 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.

- History of allergic disease or reactions likely to be exacerbated by any component of

the vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including

human immunodeficiency virus (HIV) infection.

- Acute disease at the time of enrolment.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal

functional abnormality, as determined by physical examination or laboratory screening tests.

- Administration of immunoglobulins and/or any blood products within the three months

preceding the hepatitis B vaccine challenge dose or planned administration during the study period.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive


Locations and Contacts

Additional Information

Starting date: April 2008
Last updated: August 6, 2009

Page last updated: August 20, 2015

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