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Completed

NCT Number: NCT00519649

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

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.

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Key information

Conditions

Hepatitis B Vaccine Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Birkenfeld, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Engerix™-B Kinder

Biological

Intramuscular injection, 1 dose

Primary outcomes

  1. Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value

    Time frame: 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 outcomes

  1. Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value

    Time frame: Before challenge dose of HBV vaccine

    Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL

  2. Number of Participants Reporting Solicited Local Symptoms

    Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.

    Solicited local symptoms assessed include pain, redness and swelling

  3. Number of Participants Reporting Solicited General Symptoms

    Time frame: 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

  4. Number of Participants Reporting Unsolicited Adverse Events

    Time frame: 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.

  5. Number of Participants Reporting Serious Adverse Events (SAE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2007
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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