Back to resultsStudy to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Meningococcal vaccine GSK134612
Meningitec™
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Meningococcal vaccine GSK134612
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
Exclusion Criteria:
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject's first visit.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study 109670.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study 109670.
- Hypersensitivity to latex.
- Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- Previous vaccination with any component of the vaccines within the last month.
- History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of vaccination.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- 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 vaccine 134612 in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
Subjects who received Meningitec™ vaccine in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
Outcomes
Primary Outcome Measures
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Secondary Outcome Measures
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off value for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values
The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination
Number of Subjects Reporting Any Adverse Events (AEs)
Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00955682
Brief Title
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
Official Title
Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2009 (Actual)
Primary Completion Date
December 16, 2009 (Actual)
Study Completion Date
September 10, 2012 (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 12 to 23 months of age. This extension study 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
This study will assess the long-term protection offered by the new meningococcal vaccine GSK 134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine GSK 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension study. No new subjects will be enrolled. The subjects will have a blood sample taken at 24, 36 and 48 months after primary vaccination.
At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood samples will be taken 1 and 12 months after the booster 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 GSK134612
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects who received GSK vaccine 134612 in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects who received Meningitec™ vaccine in the primary vaccination study 109069 and will be boosted 4 years after primary vaccination with the same meningococcal vaccine as given in the primary study.
Intervention Type
Biological
Intervention Name(s)
Meningococcal vaccine GSK134612
Intervention Description
One intramuscular dose (Booster)
Intervention Type
Biological
Intervention Name(s)
Meningitec™
Intervention Description
One intramuscular dose (Booster)
Primary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
Description
The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
Time Frame
At Month 24 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 36 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 48 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
The cut-off value for the assay was ≥ 1:8. The rSBA-MenA results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 36 post-primary vaccination.
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 48 post-primary vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory.
Time Frame
At Month 24 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 36 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:128. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 48 post primary vaccination
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
The results for the assay were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured at the GlaxoSmithKline (GSK) laboratory
Time Frame
At Months 24 post primary vaccination
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 36 post primary vaccination
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 48 post primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 36 post-primary vaccination
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off value for the assay was ≥ 1:128. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 48 post-primary vaccination
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 3 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 36 post-primary vaccination
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres. rSBA-MenA, MenC, MenW and MenY results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 48 post-primary vaccination
Title
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Description
The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 24 post primary vaccination
Title
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Description
The cut-off for the assay were ≥ 1:4 and 1:8. The analysis of this endpoint was performed by GSK.
Time Frame
At Month 36 post primary vaccination
Title
Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off
Description
The cut-off for the assay were ≥ 1:4 and 1:8, as assessed by the GSK laboratory.
Time Frame
At Month 48 post primary vaccination
Title
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Description
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
Time Frame
At Month 24 post primary vaccination
Title
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Description
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory.
Time Frame
At Month 36 post primary vaccination
Title
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Description
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by GSK.
Time Frame
At Month 48 post primary vaccination
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off values for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively, as measured at the GlaxoSmithKline (GSK) laboratory.
Time Frame
At Month 24 post primary vaccination
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by the GSK laboratory.
Time Frame
At Month 36 post primary vaccination
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively, as measured by GSK.
Time Frame
At Month 48 post primary vaccination
Title
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured at the GlaxoSmithKline (GSK) laboratory.
Time Frame
At Month 24 post primary dose
Title
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Time Frame
At Month 36 post primary vaccination
Title
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expresssed in μg/mL, as measured by GSK.
Time Frame
At Month 48 post primary dose
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 0.2 μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 36 post-primary vaccination
Title
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off values for the assay were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL, respectively. Anti-PS results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 48 post-primary vaccination
Title
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 3 time point were obtained by re-testing the samples in parallel at Public Health England (PHE). Results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL.
Time Frame
At Month 36 post-primary vaccination
Title
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL. Anti-PS results for the Year 4 time point obtained by re-testing the samples in parallel at Public Health England (PHE).
Time Frame
At Month 48 post-primary vaccination.
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
Description
The cut-off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
Time Frame
At one month (Month 49) post booster dose
Title
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values
Description
The cut off values for the assay were 1:8 and 1:128, as measured by the PHE laboratory.
Time Frame
At 12 months (Month 60) post booster dose
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as measured by the PHE laboratory.
Time Frame
At one month (Month 49) post booster dose
Title
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres
Description
Results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, as measured by the PHE laboratory.
Time Frame
At 12 months (Month 60) post booster dose
Title
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
Description
The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK.
Time Frame
At one month (Month 49) post booster dose
Title
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values
Description
The cut off values for the assay were ≥ 1:4 and ≥ 1:8, respectively, as measured by GSK.
Time Frame
At 12 months (Month 60) post booster dose.
Title
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Description
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
Time Frame
At one month (Month 49) post booster dose
Title
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres
Description
The results were tabulated as geometric mean antibody titre (GMT) calculated on all subjects, expressed in titres, as measured by GSK.
Time Frame
At 12 months (Month 60) post booster dose
Title
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values
Description
The cut-off values for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Time Frame
At one month (Month 49) post booster dose
Title
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values
Description
The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory.
Time Frame
At 12 months (Month 60) post booster dose
Title
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Time Frame
At one month (Month 49) post booster dose
Title
Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Description
The results were tabulated as geometric mean antibody concentration calculated on all subjects, expressed in μg/mL, as measured by the PHE laboratory.
Time Frame
At 12 months (Month 60) post booster dose
Title
Number of Subjects Reporting Any Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Time Frame
During the 8-day period (Days 0-7) after booster vaccination
Title
Number of Subjects Reporting Any Solicited General Symptoms
Description
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite, temperature (measured orally). Any was defined as occurrence of any general symptoms, regardless of their intensity grade or their relationship to vaccination
Time Frame
During the 8-day period (Days 0-7) after the booster vaccination
Title
Number of Subjects Reporting Any Adverse Events (AEs)
Description
Any was defined as the occurrence of any adverse event regardless of intensity grade or relation to vaccination. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.
Time Frame
During the 31-day period (Days 0-30) after booster vaccination
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time Frame
At Month 24 post primary dose
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time Frame
At Month 36
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time Frame
At Month 48
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time Frame
From month 48 to month 49 (post booster follow up period)
Title
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Time Frame
From month 49 to month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
Written informed consent obtained from the parent(s) or guardian(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
Exclusion Criteria:
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject's first visit.
History of meningococcal disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study 109670.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study 109670.
Hypersensitivity to latex.
Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
Previous vaccination with any component of the vaccines within the last month.
History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
Major congenital defects or serious chronic illness.
Acute disease at the time of vaccination.
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
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Kotka
ZIP/Postal Code
48600
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
26780033
Citation
Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.
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
112036
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
112036
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
112036
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
112036
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
112036
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
112036
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 Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
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