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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
342
One intramuscular dose (Booster)
One intramuscular dose (Booster)
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Helsinki, Finland
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.
Time frame: At Month 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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).
Time frame: At Month 36 post-primary vaccination.
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).
Time frame: At Month 48 post-primary vaccination
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.
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GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kotka, Finland
GSK Investigational Site
Kuopio, Finland
GSK Investigational Site
Lahti, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Pori, Finland
GSK Investigational Site
Seinäjoki, Finland
...and 4 more locations
Time frame: At Month 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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
Time frame: At Months 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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).
Time frame: At Month 36 post-primary vaccination
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).
Time frame: At Month 48 post-primary vaccination
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).
Time frame: At Month 36 post-primary vaccination
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).
Time frame: At Month 48 post-primary vaccination
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.
Time frame: At Month 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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.
Time frame: At Month 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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.
Time frame: At Month 24 post primary vaccination
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary vaccination
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.
Time frame: At Month 24 post primary dose
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.
Time frame: At Month 36 post primary vaccination
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.
Time frame: At Month 48 post primary dose
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).
Time frame: At Month 36 post-primary vaccination
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).
Time frame: At Month 48 post-primary vaccination
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.
Time frame: At Month 36 post-primary vaccination
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).
Time frame: At Month 48 post-primary vaccination.
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose.
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose
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.
Time frame: At one month (Month 49) post booster dose
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.
Time frame: At 12 months (Month 60) post booster dose
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.
Time frame: During the 8-day period (Days 0-7) after booster vaccination
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
Time frame: During the 8-day period (Days 0-7) after the booster 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.
Time frame: During the 31-day period (Days 0-30) after booster 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.
Time frame: At Month 24 post primary dose
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.
Time frame: At Month 36
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.
Time frame: At Month 48
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.
Time frame: From month 48 to month 49 (post booster follow up period)
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.
Time frame: From month 49 to month 60