Hepatitis B Clinical Trial
Official title:
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder
Verified date | June 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.
Status | Completed |
Enrollment | 303 |
Est. completion date | February 21, 2014 |
Est. primary completion date | February 21, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Subject's parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. - A male or female between, and including, 15 and 16 years of age at the time of the vaccination. - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s). - Healthy subjects as established by medical history and clinical examination before entering into the study. - Documented evidence of previous vaccination with three consecutive doses of Engerix™-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age. - Female subjects of non-childbearing potential may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination. Exclusion Criteria: - Child in care. - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone = 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. - Previous hepatitis B vaccination since administration of the third dose of Engerix™-B Kinder. - History of hepatitis B disease. - Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Acute disease and/or fever at the time of enrollment. - Fever is defined as temperature = 37.5°C for oral, axillary or tympanic route, or = 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. - Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions. |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Bindlach | Bayern |
Germany | GSK Investigational Site | Flensburg | Schleswig-Holstein |
Germany | GSK Investigational Site | Frankenthal | Rheinland-Pfalz |
Germany | GSK Investigational Site | Goch | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Kehl | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Kirchheim | Bayern |
Germany | GSK Investigational Site | Leipzig | Sachsen |
Germany | GSK Investigational Site | Neumuenster | |
Germany | GSK Investigational Site | Tuttlingen | Baden-Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value. | The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL). | One month after the challenge dose (Month 1) | |
Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value. | The cut-off values defined were = 6.2 mIU/mL, = 10 mIU/mL and = 100 mIU/mL. | Before (Day 0) and one month after the challenge dose (Month 1) | |
Secondary | Antibody Titers Against Hepatitis B Virus | Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs. | Before (Day 0) and one month (Month 1) after the challenge dose | |
Secondary | Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status. | Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations =10 mIU/mL in subjects seronegative at the pre-vaccination time point |
Prior to vaccination with the challenge dose | |
Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm. | During the 4-day (Days 0-3) follow-up period after the challenge dose | |
Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C | During the 4-day (Days 0-3) follow-up period after the challenge dose | |
Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) follow-up period after the challenge dose | |
Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | During the entire study period (Day 0 to Month 1) |
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