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Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

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ClinicalTrials.gov Identifier: NCT00289731
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition or disease Intervention/treatment Phase
Hepatitis B Hepatitis A Biological: TWINRIX™ Biological: Engerix™-B Biological: HAVRIX™ Biological: HB VAX PRO™ Biological: Vaqta™ Phase 4

Detailed Description:
The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
Actual Study Start Date : November 24, 2003
Actual Primary Completion Date : December 21, 2004
Actual Study Completion Date : December 21, 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Twinrix Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix™ (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
Biological: TWINRIX™
Intramuscular injection, 3 doses

Active Comparator: Engerix-B+Havrix Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
Biological: Engerix™-B
Intramuscular injection, 3 doses

Biological: HAVRIX™
Intramuscular injection, 2 doses

Active Comparator: HB VAX PRO+Vaqta Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
Biological: HB VAX PRO™
Intramuscular injection, 3 doses

Biological: Vaqta™
Intramuscular injection, 2 doses




Primary Outcome Measures :
  1. Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens [ Time Frame: At Month 7 after Twinrix vaccination ]
    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

  2. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value [ Time Frame: At Month 7 ]
    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.

  3. Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen [ Time Frame: At Month 7 ]
    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.


Secondary Outcome Measures :
  1. Anti-HAV and Anti-HBs Antibody Concentrations [ Time Frame: At Month 7 ]
    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

  2. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by gender (females and males).


  3. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.


  4. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI) [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by BMI as follows: healthy, overweight and obese.


  5. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by smoking status (smokers and non-smokers).


  6. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by alcohol consumption as follows: None or Mild, Moderate and Heavy.


  7. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by concomitant medication (concomitant medication and no concomitant medication).


  8. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition [ Time Frame: At Month 7 ]

    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL.

    The seropositivity rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.


  9. Number of Seroprotected Subjects Against HBs Antigen, by Gender [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by gender (females and males).


  10. Number of Seroprotected Subjects Against HBs Antigen, by Age [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.


  11. Number of Seroprotected Subjects Against HBs Antigen, by BMI [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by BMI as follows: healthy, overweight and obese.


  12. Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by smoking status (smokers and non-smokers).


  13. Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by alcohol consumption as follows: none or mild, moderate and heavy.


  14. Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by concomitant medication (concomitant medication and no concomitant medication).


  15. Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition [ Time Frame: At Month 7 ]

    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.

    The seroprotection rates were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.


  16. Anti-HAV and Anti-HBs Antibody Concentrations, by Gender [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by gender (females and males).


  17. Anti-HAV and Anti-HBs Antibody Concentrations, by Age [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by age as follows: ≤ 50 years of age (YOA), 51-60 YOA and ≥ 61 YOA.


  18. Anti-HAV and Anti-HBs Antibody Concentrations, by BMI [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by BMI as follows: healthy, overweight and obese.


  19. Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by smoking status (smokers and non-smokers).


  20. Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by alcohol consumption as follows: none or mild, moderate and heavy.


  21. Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by concomitant medication (concomitant medication and no concomitant medication).


  22. Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition [ Time Frame: At Month 7 ]

    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.

    The antibody concentrations were stratified by medical condition as follows: no medical condition, past medical condition and current medical condition.


  23. Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value [ Time Frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36) ]
    Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL and anti-HBs seropositivity was defined as anti-HBs antibody concentrations ≥ 3.3 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).

  24. Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen [ Time Frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36) ]
    A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).

  25. Anti-HAV and Anti-HBs Antibody Concentrations [ Time Frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36) ]
    Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively. Anti-HBs AUSAB = anti-HBs antibody concentrations were tested with AUSAB EIA /Abbott assay; Anti-HBs in-house = anti-HBs antibody concentrations were tested with in-house assay (bridging).

  26. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to Month 7 ]

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.


  27. Number of Subjects With SAEs [ Time Frame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36) ]

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Note: 3 subjects reported SAEs prior to administration of the first dose of vaccination.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
  • Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • No serological signs of hepatitis A or B infection at screening.
  • 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 completion of the vaccination series.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study 100382.
  • 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.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289731


Locations
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Czechia
GSK Investigational Site
Hradec Kralove, Czechia, 500 01
Germany
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100382 are summarised with studies 100383, 100384, and 100385 on the GSK Clinical Study Register.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100382
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289731     History of Changes
Other Study ID Numbers: 100382
100383 ( Other Identifier: GSK )
100384 ( Other Identifier: GSK )
100385 ( Other Identifier: GSK )
First Posted: February 10, 2006    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Combined hepatitis A and hepatitis B vaccine
Hepatitis B
Hepatitis A
Monovalent hepatitis A and hepatitis B vaccines

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