NCT01154088CompletedPhase 3
Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 Years
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,170
- Locations
- 3
- Primary Endpoint
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Study Overview
Brief Summary
The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All subjects must satisfy all of the following criteria at study entry:
- •Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
- •A male or female between, and including, 18 and 25 years of age the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •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 vaccination.
Exclusion Criteria
- •The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
- •Use of any investigational or non-registered product other than the study vaccine(s) 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 vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
- •Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
- •Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
- •Previous vaccination with meningococcal conjugate vaccine.
- •Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
- •History of meningococcal disease.
- •Seropositive for HIV or HBsAg (for subjects in the Philippines only).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient has been demonstrated.
- •History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- •History of any neurologic disorders, including Guillain-Barré Syndrome.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •History of chronic alcohol consumption and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- •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 product.
Arms & Interventions
Group A
Experimental
Intervention: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] (Biological)
Group B
Experimental
Intervention: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] (Biological)
Group C
Active Comparator
Intervention: Mencevax ACWY (Biological)
Outcomes
Primary Outcomes
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Time Frame: At Month 1
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
Time Frame: At Month 1
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Secondary Outcomes
- Number of Subjects With New Onset Chronic Illnesses (NOCI)(Within 31-days (Days 0-30) post-vaccination)
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(At Day 0)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value(At Day 0 and at Month 1)
- Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies(At Month 1)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31-days (Days 0-30) post-vaccination)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value(At Day 0 and Month 1)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 4-days (Days 0-3) post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 4-days (Days 0-3) post-vaccination)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value(At Day 0 and at Month 1)
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(At Day 0 and at Month 1)
Investigators
Study Sites (3)
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