Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612

Study Overview
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Brief Summary
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This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Detailed Description
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Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. No additional vaccines will be administered during this study and no new subjects will be enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.

Official Title
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Assess Long Term Persistence of a Primary Dose of GSK Biologicals' Meningococcal Vaccine 134612 Versus One Dose of Mencevax™ ACWY in Healthy Adolescents/Young Adults (15 to 19 Years at Vaccination)

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: Meningococcal vaccine 134612
* Biological: Mencevax™ ACWY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study. Written informed consent obtained from the subject/ from the parent or guardians of the subject. Written informed assent obtained from the subject, as applicable, at the time of study entry. Exclusion Criteria: • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects previously primed with meningococcal vaccine 134612. | Biological: Meningococcal vaccine 134612<br>* One intramuscular dose during the primary study<br>|
| Active Comparator: Group B<br>Subjects previously primed with Mencevax™ ACWY. | Biological: Mencevax™ ACWY<br>* One subcutaneous dose during the primary study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meningococcal rSBA titres. |  | At the start of this persistence study and 12 and 24 months later. | 
| Anti-meningococcal polysaccharide concentrations |  | At the start of this persistence study and 12 and 24 months later. | 
| Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation. |  | From the last study contact of the primary vaccination study to the end of this persistence study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Meningococcal vaccine, Conjugate vaccine, Persistence