Hepatitis B Clinical Trial
Official title:
Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15
NCT number | NCT00697775 |
Other study ID # | 208129/028 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | June 12, 2008 |
Last updated | June 13, 2008 |
Start date | March 1998 |
Verified date | June 2008 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ministry of Health |
Study type | Interventional |
In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
Status | Completed |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | May 1999 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 11 Years to 15 Years |
Eligibility |
Inclusion Criteria: - Age: between 11 and 15 years at the time of the first vaccination. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age. - If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month 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 drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. - Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. - Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after. - Previous vaccination against hepatitis B virus. - Previous vaccination with vaccine containing MPL. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Acute disease at the time of enrollment. - Hepatomegaly, right upper quadrant abdominal pain or tenderness. - Axillary temperature of = 37.5° C. - Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period. - Pregnant or lactating female. - History of chronic disease deemed by the investigator to be relevant. - Positive for anti-HBV antibodies at screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | GSK Clinical Trials Call Center | Mainz |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Serious adverse experiences (SAE) | During the study period | ||
Primary | Occurrence, intensity and relationship to vaccination of solicited local and general symptoms | During the 8-day follow-up period after vaccination | ||
Primary | Occurrence, intensity and causal relationship of unsolicited adverse events | 31-day follow-up period after vaccination | ||
Secondary | Anti-HBs antibody concentrations | At months 1, 2, 6, and 7 | ||
Secondary | Cell mediated immunity | At months 1, 6, and 7 |
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