Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00684671
First received: May 23, 2008
Last updated: June 14, 2012
Last verified: June 2012

May 23, 2008
June 14, 2012
May 2008
November 2008   (final data collection date for primary outcome measure)
  • Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]

    Anamnestic response was defined as:

    • for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],
    • for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,
    • for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration.
  • Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]

    Anamnestic response was defined as :

    • for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),
    • for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration.
  • Anti-HAV antibody response to the challenge dose [ Time Frame: One month after the challenge dose. ]
  • Anti-HBs antibody response to the challenge dose [ Time Frame: One month after the challenge dose ]
Complete list of historical versions of study NCT00684671 on ClinicalTrials.gov Archive Site
  • Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Prior to administration of challenge dose ] [ Designated as safety issue: No ]
    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.
  • Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Two weeks and one month after the challenge dose ] [ Designated as safety issue: No ]
    Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).
  • Number of Subjects Reporting Unsolicited Symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
    Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
  • Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination [ Time Frame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) ] [ Designated as safety issue: No ]
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During one month following the administration of the challenge dose ] [ Designated as safety issue: No ]
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.
  • Anti-HAV and anti-HBs antibody concentrations at Month 48 [ Time Frame: At Month 48 after primary vaccination ]
  • Anti-HAV antibody concentrations after the challenge dose [ Time Frame: Two weeks and one month after the challenge dose. ]
  • Anti-HBs antibody concentrations after the challenge dose. [ Time Frame: Two weeks and one month after the challenge dose. ]
  • Occurrence and intensity of solicited local symptoms. [ Time Frame: 4-day follow-up period after vaccination ]
  • Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 4-day follow-up period after vaccination ]
  • Retrospective recording of all serious adverse events (SAEs) with causal relationship to vaccination or referring to hepatitis A or B infection that occurred since the last study visit of the HAB-160 long-term follow-up study. [ Time Frame: since the last study visit of the HAB-160 long-term follow-up study. ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: 31-day follow-up period after challenge dose. ]
  • Occurrence, intensity and relationship to vaccination of all SAEs following the administration of the challenge dose. [ Time Frame: Following the administration of the challenge dose. ]
Not Provided
Not Provided
 
Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Viral Hepatitis Vaccines
  • Hepatitis B
  • Hepatitis A
  • Biological: Twinrix
    Intramuscular injection, single dose in left deltoid.
  • Biological: Engerix-B
    Intramuscular injection, single dose in left deltoid.
  • Biological: Havrix
    Intramuscular injection, single dose in right deltoid.
  • Biological: HBVAXPRO
    Intramuscular injection, single dose in the left deltoid.
  • Biological: Vaqta
    Intramuscular injection, single dose in right deltoid.
  • Experimental: Twinrix Group
    Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
    Intervention: Biological: Twinrix
  • Active Comparator: Engerix + Havrix Group
    Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
    Interventions:
    • Biological: Engerix-B
    • Biological: Havrix
  • Active Comparator: HB VAX PRO + Vaqta Group
    Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
    Interventions:
    • Biological: HBVAXPRO
    • Biological: Vaqta
Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
506
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female who completed the primary vaccination phase of the HAB-160 study (NCT 00603252).
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential; 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 the time of study entry. If any apply, the subject must not be included in the study:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
  • History of any hepatitis A or hepatitis B vaccination or infection since the primary vaccination study.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
Both
41 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic
 
NCT00684671
111572
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP