Back to resultsStudy to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Blood Sampling
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring meningococcal vaccine GSK 134612
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- 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 who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Secondary Outcome Measures
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Antibody Titers Against the Vaccine Meningococcal Serogroups
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against the Vaccine Polysaccharides
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00974363
Brief Title
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Official Title
Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
Detailed Description
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 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
meningococcal vaccine GSK 134612
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
697 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
Intervention Type
Procedure
Intervention Name(s)
Blood Sampling
Intervention Description
A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Description
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
Time Frame
At Month 24 post primary dose
Title
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Description
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Time Frame
At Month 36 post primary dose
Title
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Description
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Time Frame
At Month 48 post primary dose
Title
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Description
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Time Frame
At Month 60 post primary dose
Secondary Outcome Measure Information:
Title
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
Description
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Time Frame
At Months 24, 36, 48 and 60 post primary dose
Title
Antibody Titers Against the Vaccine Meningococcal Serogroups
Description
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Time Frame
At Months 24, 36, 48 and 60 post primary dose
Title
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Description
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
At Month 24 post primary dose
Title
Antibody Concentrations Against the Vaccine Polysaccharides
Description
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
At Month 24 post primary dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
History of meningococcal disease; such cases will be documented.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
Subjects who withdrew consent to be contacted for follow-up studies.
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
Goa
ZIP/Postal Code
403202
Country
India
Facility Name
GSK Investigational Site
City
Indore
ZIP/Postal Code
452001
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411 011
Country
India
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
12. IPD Sharing Statement
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Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
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