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Completed

NCT Number: NCT00343915

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.

Subjects were aged 11 to 15 years at the time of the primary vaccination course.

At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.

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 Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Sydney, New South Wales, Australia

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About this study

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects have participated in primary study HBV-280
  • Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Treatment and study plan

Engerix™-B (thiomersal-free) 20µg

Biological

In the primary study: 2 deep intramuscular injections (Months 0, & 6)

10 μg Engerix™-B (preservative-free)

Biological

In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)

Placebo

Biological

In the primary study: 1 deep intramuscular injection (month 1)

Primary outcomes

  1. Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.

    Time frame: At Month 7

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  2. Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.

    Time frame: At Month 30, Month 42, Month 54 and Month 66

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  3. Antibody Titers Against Hepatitis-B Virus.

    Time frame: At Month 30, Month 42, Month 54 and Month 66

    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

Secondary outcomes

  1. Antibody Titers Against Hepatitis-B Virus.

    Time frame: At Months 1, 2, 6 and 7

    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

  2. Number of Subjects Seroprotected for Anti-HBs Antibody.

    Time frame: At Months 1, 2 and 6

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  3. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Time frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall

    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  4. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

    Time frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall

    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

  5. Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).

    Time frame: During the 31-day (Day 0-30) follow-up period after each vaccination and overall

    An unsolicited AE covers 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.

  6. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the entire study period (Month 0 to Month 66)

    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

  7. Number of Subjects With Serious Adverse Events (SAEs).

    Time frame: At Month 30, Month 42, Month 54 & Month 66

    erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jun 23, 2006
Registry last updated
Jun 10, 2019

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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