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Phase 4 N=596 Randomized Prevention

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

Hepatitis B · Hepatitis A

Enrolled (actual)
596
Serious AEs
6.9%
Results posted
Oct 2018
Primary outcome: Primary: Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens — 2746.5; 1153.9 mIU/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
TWINRIX™ (Biological); Engerix™-B (Biological); HAVRIX™ (Biological); HB VAX PRO™ (Biological); Vaqta™ (Biological)
Age
Adult, Older Adult · 41+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Dec 2004

Outcome Measures

OutcomeResultp-value
PRIMARY
Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
2746.5; 1153.9
PRIMARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
162; 165; 164; 164; 170; 163
PRIMARY
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
147; 124; 93; 127; 88; 50
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations
891.0; 530.6; 1200.5; 271.6; 209.9; 362.0
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender
86; 88; 89; 90; 92; 85
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age
58; 59; 59; 63; 63; 57
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)
57; 61; 58; 66; 63; 58
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status
50; 51; 32; 126; 129; 142
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption
108; 105; 100; 55; 67; 62
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication
160; 167; 160; 16; 13; 14
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition
24; 20; 20; 13; 22; 15
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Gender
82; 73; 75; 84; 72; 50
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Age
57; 48; 52; 63; 55; 43
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by BMI
52; 51; 46; 62; 51; 40
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status
47; 42; 22; 119; 103; 103
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption
105; 87; 76; 50; 52; 41
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication
151; 135; 117; 15; 10; 8
SECONDARY
Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition
23; 18; 13; 13; 18; 12
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Gender
2968.1; 2089.2; 5307.0; 2550.3; 947.0; 2546.4
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Age
4034.0; 1769.8; 5166.9; 2521.6; 1714.8; 3822.8
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by BMI
3565.4; 1569.2; 4756.2; 2846.6; 1663.9; 3943.9
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status
1844.6; 1433.2; 3456.0; 3216.5; 1379.2; 3766.3
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption
2505.1; 1403.6; 3731.1; 3174.6; 1453.8; 3754.3
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication
2680.3; 1398.4; 3752.7; 3505.5; 1343.0; 3225.1
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition
4765.5; 2187.5; 5531.9; 3438.3; 1882.2; 4073.9
SECONDARY
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
162; 165; 164; 164; 170; 163
SECONDARY
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
147; 124; 93; 127; 88; 50
SECONDARY
Anti-HAV and Anti-HBs Antibody Concentrations
891.0; 530.6; 1200.5; 271.6; 209.9; 362.0
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
11; 14; 16
SECONDARY
Number of Subjects With SAEs
0; 0; 0; 0; 0; 0

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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