NCT00697125CompletedPhase 2
Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Occurrence and intensity of solicited local and general symptoms
Study Overview
Brief Summary
The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Serological signs of HBV infection
- •Elevated serum liver enzymes
- •Any vaccination against hepatitis B in the past.
- •Any previous administration of MPL.
- •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.
- •Administration of any other vaccine(s) or any immunoglobulin during the study period.
- •Simultaneous participation in any other clinical trial.
Arms & Interventions
Group A
Active Comparator
Intervention: Engerix™-B (Biological)
Group B
Experimental
Intervention: Hepatitis B vaccine, experimental formulation (Biological)
Group C
Experimental
Intervention: HBV-MPL vaccine (208129) (Biological)
Outcomes
Primary Outcomes
Occurrence and intensity of solicited local and general symptoms
Time Frame: 8 days follow-up after vaccination
Secondary Outcomes
- Anti-HBs antibody concentrations(Months 0, 1, 3, 6, 7, 8 and 12)
- Occurrence, intensity of unsolicited adverse events(30-day follow-up after vaccination)
- Occurrence of serious adverse events(During the study period up to 30 days after last vaccination)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 YearsInfluenza, HumanNCT03275389GlaxoSmithKline470
Completed
Phase 3
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-BHepatitis BNCT00698087GlaxoSmithKline60
Completed
Phase 2
Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell LymphomaInfluenzaNCT00307177National Institute of Allergy and Infectious Diseases (NIAID)28
Completed
Phase 3
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-RespondersHepatitis BNCT00697931GlaxoSmithKline116
Completed
Phase 1
Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory AdultsInfluenzaNCT00133471National Institute of Allergy and Infectious Diseases (NIAID)96