Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Meningococcal vaccine 134612
Mencevax™ ACWY
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Immunogenicity, Meningococcal vaccine, Conjugate vaccine, Persistence
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Subjects previously primed with meningococcal vaccine 134612.
Subjects previously primed with Mencevax™ ACWY.
Outcomes
Primary Outcome Measures
Meningococcal rSBA titres.
Anti-meningococcal polysaccharide concentrations
Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390143
Brief Title
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Immunogenicity, Meningococcal vaccine, Conjugate vaccine, Persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects previously primed with meningococcal vaccine 134612.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects previously primed with Mencevax™ ACWY.
Intervention Type
Biological
Intervention Name(s)
Meningococcal vaccine 134612
Intervention Description
One intramuscular dose during the primary study
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACWY
Intervention Description
One subcutaneous dose during the primary study
Primary Outcome Measure Information:
Title
Meningococcal rSBA titres.
Time Frame
At the start of this persistence study and 12 and 24 months later.
Title
Anti-meningococcal polysaccharide concentrations
Time Frame
At the start of this persistence study and 12 and 24 months later.
Title
Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.
Time Frame
From the last study contact of the primary vaccination study to the end of this persistence study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23246368
Citation
Ostergaard L, Van der Wielen M, Bianco V, Miller JM. Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT). Int J Infect Dis. 2013 Mar;17(3):e173-6. doi: 10.1016/j.ijid.2012.10.001. Epub 2012 Dec 13.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108595 Mth18
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
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