Back to resultsStudy to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Meningococcal (vaccine)
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal
Eligibility Criteria
Inclusion criteria: Healthy male or female between, and including, 18 and 25 years of age at the time of vaccination. Written informed consent obtained. Subject with previously completed routine childhood vaccinations to the best of his/her knowledge. Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception. 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. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. History of chronic alcohol consumption and/or drug abuse
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.
Secondary Outcome Measures
Sol (d 0-7, local&general), unsol (d 0-30) symptoms. SAEs. Routine blood & urine examination before, 2&7 d post vacc. % SBA-MenA C W Y responders 1m post vacc. Antibodies to MenA C W Y before, 1, 12, 24&36m post vacc & tetanus before, 1m post vacc
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00196950
Brief Title
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Official Title
Assess the Safety, Reactogenicity, Immunogenicity & Long-term Persistence of One Intramuscular Dose of GSK Biologicals' MenACWY Conjugate Vaccine vs One Subcutaneous Dose of Mencevax™ ACWY in Healthy Adults Aged 18-25 Yrs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.
Detailed Description
Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. The study consists of a vaccination phase during which subjects receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine) and 3 years of follow-up. There are in total 7 visits to the doctor: before and 2, 7 and 30 days after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination (follow-up phase). 7 blood samples are taken: one at each visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Meningococcal (vaccine)
Primary Outcome Measure Information:
Title
The occurrence of any grade 3 solicited symptoms within 8 days (day 0-7) following vaccination.
Secondary Outcome Measure Information:
Title
Sol (d 0-7, local&general), unsol (d 0-30) symptoms. SAEs. Routine blood & urine examination before, 2&7 d post vacc. % SBA-MenA C W Y responders 1m post vacc. Antibodies to MenA C W Y before, 1, 12, 24&36m post vacc & tetanus before, 1m post vacc
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy male or female between, and including, 18 and 25 years of age at the time of vaccination.
Written informed consent obtained.
Subject with previously completed routine childhood vaccinations to the best of his/her knowledge.
Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception.
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.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
History of chronic alcohol consumption and/or drug abuse
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
Gosselies
ZIP/Postal Code
6041
Country
Belgium
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
18834910
Citation
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. doi: 10.1016/j.vaccine.2008.08.075. Epub 2008 Oct 1. Erratum In: Vaccine. 2009 Dec 9;27(52):7467.
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
134612/003
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
134612/003
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
134612/003
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 134612/003 are summarised with studies 102252, 102253, and 102254 on the GSK Clinical Study Register.
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
134612/003
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
134612/003
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
134612/003
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
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