Not Signed In -
Meningitis |
bacterial and viral |
Clinical Trial: Study to Evaluate Four Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as One Dose to Healthy Subjects Aged 15-19 Years
This study is currently recruiting patients.
Verified by GlaxoSmithKline August 2005
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Purpose
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
| Condition | Intervention | Phase |
|---|---|---|
| Meningitis, Meningococcal | Vaccine: Meningococcal Vaccine | Phase II |
MedlinePlus related topics: Bacterial Infections; Meningitis; Neurologic Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Open, Randomized, Controlled, Primary Vaccination Study to Assess the Immunogenicity, Safety and Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals’ Meningococcal Conjugate Vaccine (MenACWY) Versus 1 Dose of MENCEVAX™ ACWY in Healthy Subjects Aged 15-19 Years
Further Study Details:
Primary Outcomes: Percentage of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in serum bactericidal antibody [SBA] titre from pre to post vaccination) at 1 month after the first vaccine dose
Secondary Outcomes: Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster; Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)
Expected Total Enrollment: 125
Secondary Outcomes: Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster; Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)
Expected Total Enrollment: 125
Study start: August 2005
The study is open. However, the 4 different formulations of GSK''''s MenACWY conjugate vaccine will be administered in a double-blind manner. Mencevax™ ACWY vaccine will serve as active control. Subjects will receive one vaccine dose only (GSK''''s MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.
Eligibility
Ages Eligible for Study: 15 Years - 19 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
- Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents’/guardians’ knowledge.
- Female subjects should be of non-childbearing potential.
Exclusion Criteria:
- Previous vaccination against OR history of OR exposure within previous 12 months to meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a tetanus vaccine within 6 months before study vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00126945
Clinical Coordinator +1.877.379.37.18
Denmark
Arhus, Denmark; Recruiting
Study chairs or principal investigators
Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: 104702
Last Updated: August 19, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00126945
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00126945
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Arachnoiditis (National Institute of Neurological Disorders and Stroke)
- Bacterial Meningitis (Directors of Health Promotion and Education)
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