Phase 4
N=596
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Hepatitis B · Hepatitis A
Bottom Line
View on ClinicalTrials.gov: NCT00289731 ↗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
| Outcome | Result | p-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.
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.