Hepatitis B Clinical Trial
Official title:
Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Verified date | June 2008 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary
Status | Completed |
Enrollment | 60 |
Est. completion date | February 1996 |
Est. primary completion date | February 1996 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Between 18 and 40 years old. - Written informed consent will have been obtained from the subjects. - Good physical condition as established by physical examination and history taking at the time of entry. - Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry Exclusion Criteria: - Pregnancy or lactation. - Positive titres for anti hepatitis B antibodies - Any vaccination against hepatitis B in the past. - Any previous administration of MPL. - Elevated serum liver enzymes. - History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. - Axillary temperature > 37.5°C at the time of injection. - Any acute disease at the moment of entry. - Chronic alcohol consumption. - Any treatment with immunosuppressive or immunostimulant therapy. - Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study. - History of allergic disease likely to be stimulated by any component of the vaccine. - Simultaneous administration of any other vaccine(s). - Administration of any immunoglobulin during the study period. - Simultaneous participation in any other clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | GSK Clinical Trials Call Center | Vienna |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-HBs antibody concentrations | At M3 and M13 | ||
Primary | Occurrence of local and general solicited symptoms | 4-day follow-up after vaccination | ||
Primary | Occurrence of unsolicited symptoms | 30-day follow-up after vaccination | ||
Secondary | SAEs | Throughout the study up to 30 days after last vaccination | ||
Secondary | Anti-HBs antibody concentrations | Months 2, 3, 6, 9, 12, 13 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |