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Completed

NCT Number: NCT00197184

Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

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 Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Enterovirus Infections Hepadnaviridae Infections Hepatitis Hepatitis A Hepatitis, Viral, Human Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, North Adelaide, South Australia, Australia

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About this study

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participation in primary study
  • Written informed consent obtained before each long term follow up visit.

Treatment and study plan

TWINRIX™ ADULT

Biological

Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.

Other names: Combined hepatitis A and B vaccine

Twinrix™ Junior

Biological

Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Other names: Combined hepatitis A and B vaccine

Primary outcomes

  1. Anti-hepatitis A (HAV) Antibody Concentrations

    Time frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

    Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)

  2. Anti-hepatitis B (HBs) Antibody Concentrations

    Time frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

    Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).

  3. Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.

    Time frame: Before and one month after additional vaccination

    Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.

  4. Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.

    Time frame: Before and One month after additional vaccination

    Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).

Secondary outcomes

  1. Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.

    Time frame: From last study visit of the primary study up to Year 5 long term follow-up

    A serious adverse event (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.

  2. Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms

    Time frame: during the 4-day follow-up period after additional vaccination

    Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.

    Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful

  3. Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.

    Time frame: During the 4-day follow-up period after additional vaccination

    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.

    Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination

  4. Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).

    Time frame: During the 30-day follow-up period after additional vaccination.

    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 Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events

    Time frame: At least one month after additional vaccination

    A serious adverse event (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

Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Aug 20, 2018

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

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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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