Back to resultsImmunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Meningococcal serogroup B vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Prophylaxis meningococcal serogroup B disease
Eligibility Criteria
Inclusion Criteria: Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination. Female subjects must be of non-childbearing potential. Exclusion Criteria: Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Family history of congenital or hereditary immunodeficiency. History of any neurologic disorders or seizures.
Sites / Locations
Outcomes
Primary Outcome Measures
Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed
Secondary Outcome Measures
For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
Serious adverse events [SAEs] (whole study)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00137917
Brief Title
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Official Title
A Primary Vaccination Study to Evaluate Immunogenicity, Safety and Reactogenicity of 3 Doses of GSK Biologicals/Finlay's Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Month or 0-1-6 Month Schedule to Healthy Subjects Aged 12-18 Years
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 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 immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).
Detailed Description
The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Prophylaxis meningococcal serogroup B disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
478 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Meningococcal serogroup B vaccine
Primary Outcome Measure Information:
Title
Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed
Secondary Outcome Measure Information:
Title
For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
Title
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
Title
Serious adverse events [SAEs] (whole study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
Female subjects must be of non-childbearing potential.
Exclusion Criteria:
Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Family history of congenital or hereditary immunodeficiency.
History of any neurologic disorders or seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
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
17065257
Citation
Boutriau D, Poolman J, Borrow R, Findlow J, Domingo JD, Puig-Barbera J, Baldo JM, Planelles V, Jubert A, Colomer J, Gil A, Levie K, Kervyn AD, Weynants V, Dominguez F, Barbera R, Sotolongo F. Immunogenicity and safety of three doses of a bivalent (B:4:p1.19,15 and B:4:p1.7-2,4) meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 2007 Jan;14(1):65-73. doi: 10.1128/CVI.00230-06. Epub 2006 Oct 25.
Results Reference
derived
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
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
710158/002
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
710158/002
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
710158/002
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
710158/002
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
710158/002
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
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