Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 4, 2005 | ||||
| Last Updated Date | September 29, 2011 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE |
% of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in SBA titre from pre to post vaccination) at 1 month after the first vaccine dose. | ||||
| Change History | Complete list of historical versions of study NCT00126945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
Antibodies to MenA C W Y 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 SAEs. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs | ||||
| Official Title ICMJE | A Primary Vaccination Study to Assess the Immunogenicity,Safety & Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals' Meningococcal Conjugate Vaccine (MenACWY) vs 1 Dose of MENCEVAX™ ACWY in Healthy Subjects Aged 15-19 Yrs | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Biological: Meningococcal Vaccine
Other Name: Meningococcal Vaccine |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Ostergaard L, Lebacq E, Poolman J, Maechler G, Boutriau D. Immunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15-25 years. Vaccine. 2009 Jan 1;27(1):161-8. Epub 2008 Oct 1. Erratum in: Vaccine. 2009 Dec 9;27(52):7467. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 125 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 15 Years to 19 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00126945 | ||||
| Other Study ID Numbers ICMJE | 104702 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | September 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||