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Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™.
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, April 2009
First Received: April 2, 2009   Last Updated: April 9, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00875485
  Purpose

This study will evaluate the immune response against HAV and HBs (hepatitis B surface) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.

No new subjects will be recruited during this booster phase of the study.


Condition Intervention Phase
Hepatitis A
Hepatitis B
Procedure: Blood sampling
Biological: Havrix™
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Memory
Drug Information available for: Immunoglobulins Twinrix Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Study to Evaluate Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs antibody response above or equal to the specified value and GMCs. [ Time Frame: At Year 11, 12, 13, 14 and 15. ] [ Designated as safety issue: No ]
  • Anti-HAV anamnestic response. [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]
  • Anti-HBs anamnestic response. [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]
  • Anti-HAV antibody response above or equal to the specified value and GMCs. [ Time Frame: At Year 11, 12, 13, 14 and 15. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of all SAEs. [ Time Frame: One month after the administration of the challenge dose. ] [ Designated as safety issue: No ]
  • Occurrence of SAEs and or hepatitis A or B infection. [ Time Frame: Since the last long-term follow-up visit. ] [ Designated as safety issue: No ]
  • Percentage of subjects with anti-HAV antibody concentrations above or equal to specified value and GMCs. [ Time Frame: Before and one month after the challenge dose. ] [ Designated as safety issue: No ]
  • Percentage of subjects with anti-HBs antibody concentrations above or equal to specified value and GMCs. [ Time Frame: Before and one month after the combined hepatitis A and/or hepatitis B vaccine challenge dose. ] [ Designated as safety issue: No ]
  • Occurrence and intensity of solicited local symptoms. [ Time Frame: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
  • Occurrence and intensity of solicited general symptoms. [ Time Frame: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: During the 31-day (Day 0 to 30) follow-up period after the challenge dose. ] [ Designated as safety issue: No ]

Estimated Enrollment: 235
Study Start Date: May 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: Experimental Procedure: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biological: Havrix™
Intramuscular injection, single challenge dose. This challenge dose will be administered to seronegative subjects for anti-HAV antibodies.
Group B: Experimental Procedure: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biological: Havrix™
Intramuscular injection, single challenge dose. This challenge dose will be administered to seronegative subjects for anti-HAV antibodies.

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 who received the complete primary vaccination course according to his/her group allocation in the primary study
  • Written informed consent obtained from the subject.

All subjects must satisfy the following criteria at entry into the challenge dose phase:

  • A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study.
  • Subjects who participated in the long-term follow-up phase of the primary study and for whom the antibody concentrations were below specified value for anti-HAV antibodies and/ or for anti-HBs antibodies at the last available follow-up time-points.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
  • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.

Exclusion Criteria:

The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.

  • Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the primary study.
  • History of hepatitis A or hepatitis B infection.
  • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.

The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
  • Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the primary study and the challenge dose visit.
  • History of hepatitis A or hepatitis B infection.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
  • Pregnant or lactating female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875485

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110699, 110700, 110701, 110702, 110703, 110704
Study First Received: April 2, 2009
Last Updated: April 9, 2009
ClinicalTrials.gov Identifier: NCT00875485     History of Changes
Health Authority: Belgium: Direction Générale de la Protection de la Santé Publique Médicaments;   Czech: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Monovalent Hepatitis A
hepatitis B vaccine
Belgium and Czech Republic

Study placed in the following topic categories:
Liver Diseases
Immunologic Factors
Hepatitis, Viral, Human
Picornaviridae Infections
Hepatitis
Virus Diseases
Antibodies
Digestive System Diseases
Hepatitis B
Hepatitis A
DNA Virus Infections
Enterovirus Infections
Immunoglobulins

Additional relevant MeSH terms:
Liver Diseases
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs
Hepatitis, Viral, Human
Picornaviridae Infections
Hepadnaviridae Infections
Pharmacologic Actions
Hepatitis
Virus Diseases
Antibodies
Digestive System Diseases
Hepatitis B
Hepatitis A
DNA Virus Infections
Enterovirus Infections

ClinicalTrials.gov processed this record on May 07, 2009