Hepatitis B Clinical Trial
Official title:
Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.
Verified date | March 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 506 |
Est. completion date | November 3, 2008 |
Est. primary completion date | November 3, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 41 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Wilrijk | |
Czechia | GSK Investigational Site | Hradec Kralove |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium, Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies | 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. |
One month after the challenge dose. | |
Primary | Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | 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. |
One month after the challenge dose. | |
Secondary | Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. | Prior to administration of challenge dose | |
Secondary | Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. | Two weeks and one month after the challenge dose | |
Secondary | Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius). | During the 4-day follow-up period after the challenge dose. | |
Secondary | Number of Subjects Reporting Unsolicited Symptoms | 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. | During the 31-day follow-up period after the challenge dose. | |
Secondary | 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 | 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. | Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) | |
Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | 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. | During one month following the administration of the challenge dose |
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