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Completed

NCT Number: NCT00289757

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

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Key information

Conditions

Hepatitis A Digestive System Diseases Enterovirus Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

29 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Wilrijk, 2610, Belgium

About this study

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination.

The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who had received at least one dose of the study vaccine in the primary study
  • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Treatment and study plan

Havrix™

Biological

2 doses at 6 months interval

Primary outcomes

  1. Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

    Time frame: At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination

    Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).

    The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.

  2. Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration

    Time frame: Before the additional dose, 14 days and 30 days after the additional dose

    Concentrations given as GMC expressed as mIU/mL.

  3. Number of Seropositive Subjects for Anti-HAV Antibodies.

    Time frame: From Year 11 to Year 20

    Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points.

    The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging.

Secondary outcomes

  1. Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy

    Time frame: Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination

    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

  2. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

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

    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.

    Any = incidence of a particular symptom regardless of intensity.

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

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

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

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

    Time frame: During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)

    An AE 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. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.

    Related AE = assessed by the investigator as related to the study vaccination.

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

    Time frame: During the follow-up period after additional vaccination up to Year 20

    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

Double-blind, Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Three Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 6 Month Schedule in Healthy Adult Subjects

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2006
Registry last updated
Jul 23, 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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