Infections, Meningococcal
Conditions
Keywords
Meningococcal vaccine GSK134612
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.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One intramuscular dose (Booster)
BIOLOGICALMeningitec™
One intramuscular dose (Booster)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At Month 24 post primary vaccination | 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 | At Month 36 post primary vaccination | 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 | At Month 36 post-primary vaccination. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | At Month 48 post-primary vaccination | 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). |
| 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 | At Month 24 post primary vaccination | The cut-off values for the assay were ≥ 1:4 and 1:8, respectively. The analysis of this endpoint was performed by GSK. |
| hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | At Month 24 post primary vaccination | The results were tabulated as geometric mean antibody titre calculated on all subjects, expressed in titres, as assessed by the GSK laboratory. |
| Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | At Month 24 post primary vaccination | 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. |
| Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | At Month 24 post primary dose | 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-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | At Month 36 post-primary vaccination | 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. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | At 12 months (Month 60) post booster dose | 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 rSBAMenY Titres ≥ the Cut-off | At Month 24 post primary vaccination | The cut-off value for the assay was ≥ 1:128, as measured at the GlaxoSmithKline (GSK) laboratory. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | At Month 24 post primary dose | 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 With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | At one month (Month 49) post booster dose | 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 | At 12 months (Month 60) post booster dose | The cut-off for the assay were 0.3 μg/mL and 2.0 μg/mL, as measured by the PHE laboratory. |
| Number of Subjects Reporting Any Solicited Local Symptoms | During the 8-day period (Days 0-7) after booster vaccination | 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 | During the 8-day period (Days 0-7) after the booster vaccination | 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) | During the 31-day period (Days 0-30) after booster vaccination | 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 With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | At one month (Month 49) post booster dose | The cut off values for the assay were ≥ 1:4 and ≥ 1:8 respectively, as measured by GSK. |
| Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | At Month 36 post primary vaccination | 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 | At Months 24 post primary vaccination | 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 |
Countries
Finland
Participant flow
Recruitment details
Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
Pre-assignment details
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Group (Y2 - Y 5) Subjects from Year 2, 3, 4, Month 49 and Year 5 period, vaccinated with Nimenrix vaccine in the primary study 109670 \[NCT00474266\] (Nimenrix+ Priorix-Tetra Group and Nimenrix Group) and who at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study. | 1,256 |
| Meningitec Group (Y 2- Y 5) Subjects from Year 2, 3, 4, Month 49 and Year 5 period, who received Meningitec vaccine in the primary vaccination study 109670 \[NCT00474266\] (Priorix-Tetra Group and Meningitec Group) and at Year 4 received a booster dose with the same meningococcal vaccine as given in the primary study, as the only treatment administered after the primary study. | 232 |
| Total | 1,488 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Booster Period (Month 48- 49) | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Meningitec Group (Y 2- Y 5) | Nimenrix Group (Y2 - Y 5) |
|---|---|---|---|
| Age, Continuous Booster Period Month 49 | 63.73 Months STANDARD_DEVIATION 1.84 | 63.9 Months STANDARD_DEVIATION 1.97 | 63.7 Months STANDARD_DEVIATION 1.81 |
| Age, Continuous Year 2 Period | 40.76 Months STANDARD_DEVIATION 1.85 | 41.1 Months STANDARD_DEVIATION 1.74 | 40.7 Months STANDARD_DEVIATION 1.87 |
| Age, Continuous Year 3 Period | 49.04 Months STANDARD_DEVIATION 1.82 | 49.3 Months STANDARD_DEVIATION 2.09 | 49.0 Months STANDARD_DEVIATION 1.77 |
| Age, Continuous Year 4 Period | 63.73 Months STANDARD_DEVIATION 1.84 | 63.9 Months STANDARD_DEVIATION 1.97 | 63.7 Months STANDARD_DEVIATION 1.81 |
| Age, Continuous Year 5 Period | 72.9 Months STANDARD_DEVIATION 1.7 | 72.9 Months STANDARD_DEVIATION 1.83 | 72.9 Months STANDARD_DEVIATION 1.68 |
| Race/Ethnicity, Customized Booster Period Month 49 Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Booster Period Month 49 White - Caucasian / European heritage, n (%) | 291 Participants | 47 Participants | 244 Participants |
| Race/Ethnicity, Customized Year 2 Period Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Year 2 Period White - Caucasian / European heritage, n (%) | 294 Participants | 42 Participants | 252 Participants |
| Race/Ethnicity, Customized Year 3 Period Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Year 3 Period White - Caucasian / European heritage, n (%) | 318 Participants | 47 Participants | 271 Participants |
| Race/Ethnicity, Customized Year 4 Period Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Year 4 Period White - Caucasian / European heritage, n (%) | 292 Participants | 47 Participants | 245 Participants |
| Race/Ethnicity, Customized Year 5 Period Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Year 5 Period White - Caucasian / European heritage, n (%) | 284 Participants | 46 Participants | 238 Participants |
| Sex: Female, Male Booster Period Month 49 Female | 141 Participants | 22 Participants | 119 Participants |
| Sex: Female, Male Booster Period Month 49 Male | 152 Participants | 26 Participants | 126 Participants |
| Sex: Female, Male Year 2 Period Female | 140 Participants | 20 Participants | 120 Participants |
| Sex: Female, Male Year 2 Period Male | 155 Participants | 22 Participants | 133 Participants |
| Sex: Female, Male Year 3 Period Female | 151 Participants | 22 Participants | 129 Participants |
| Sex: Female, Male Year 3 Period Male | 169 Participants | 25 Participants | 144 Participants |
| Sex: Female, Male Year 4 Period Female | 142 Participants | 22 Participants | 120 Participants |
| Sex: Female, Male Year 4 Period Male | 152 Participants | 26 Participants | 126 Participants |
| Sex: Female, Male Year 5 Period Female | 138 Participants | 22 Participants | 116 Participants |
| Sex: Female, Male Year 5 Period Male | 148 Participants | 25 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 245 | 0 / 48 |
| other Total, other adverse events | 190 / 245 | 39 / 48 |
| serious Total, serious adverse events | 2 / 245 | 0 / 48 |
Outcome results
Primary
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.
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 157 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 94 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 130 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 141 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 6 Participants |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 166 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 91 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 111 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 131 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 11 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 13 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 7 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 16 Participants |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\] , who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 185 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 175 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 192 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 190 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 31 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 29 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 22 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 24 Participants |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 224 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 210 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 232 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 231 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 33 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 32 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 22 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 28 Participants |
Primary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | 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 | rSBA-MenA [M24] | 177 Participants |
| Nimenrix Group Y2 | 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 | rSBA-MenC [M24] | 164 Participants |
| Nimenrix Group Y2 | 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 | rSBA-MenW-135 [M24] | 186 Participants |
| Nimenrix Group Y2 | 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 | rSBA-MenY [M24] | 184 Participants |
| Meningitec Group Y2 | 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 | rSBA-MenY [M24] | 24 Participants |
| Meningitec Group Y2 | 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 | rSBA-MenA [M24] | 23 Participants |
| Meningitec Group Y2 | 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 | rSBA-MenW-135 [M24] | 17 Participants |
| Meningitec Group Y2 | 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 | rSBA-MenC [M24] | 20 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M36] | 1.16 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M36] | 0.22 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M36] | 0.78 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M36] | 1.12 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M36] | 0.52 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M36] | 0.69 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M36] | 0.24 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M36] | 0.19 μg/mL |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M48] | 2.05 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M48] | 0.25 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M48] | 0.85 μg/mL |
| Nimenrix Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M48] | 0.77 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M48] | 0.83 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M48] | 1.65 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M48] | 0.35 μg/mL |
| Meningitec Group Y2 | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M48] | 0.31 μg/mL |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M60] | 4.22 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M60] | 1.81 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M60] | 9.44 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M60] | 10.31 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M60] | 2.24 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M60] | 1.41 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M60] | 0.26 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M60] | 2.93 μg/mL |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M49] | 12.61 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M49] | 8.64 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M49] | 59.06 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M49] | 38.85 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M49] | 0.56 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M49] | 1.76 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M49] | 0.34 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M49] | 13.07 μg/mL |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M36] | 0.39 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M36] | 0.21 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M36] | 0.48 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M36] | 0.89 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M36] | 0.16 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M36] | 0.27 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M36] | 0.15 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M36] | 0.19 μg/mL |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M48] | 0.39 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M48] | 0.2 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M48] | 0.46 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M48] | 0.89 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M48] | 0.16 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M48] | 0.26 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M48] | 0.15 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M48] | 0.19 μg/mL |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M24] | 0.4 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M24] | 0.22 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M24] | 0.47 μg/mL |
| Nimenrix Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M24] | 0.85 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSY [M24] | 0.15 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSA [M24] | 0.28 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSW-135 [M24] | 0.15 μg/mL |
| Meningitec Group Y2 | Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations | Anti-PSC [M24] | 0.19 μg/mL |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M36] | 5.8 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M36] | 37.8 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M36] | 52 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M36] | 33.2 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M36] | 4.1 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M36] | 2.6 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M36] | 2.4 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M36] | 6.2 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M60] | 88 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M60] | 1342.3 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M60] | 2196.6 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M60] | 1110.8 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M60] | 7.5 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M60] | 2.5 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M60] | 3.4 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M60] | 931.1 Titres |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M49] | 1343.2 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M49] | 15831.4 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M49] | 14411.2 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M49] | 6775.5 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M49] | 4.9 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M49] | 2.8 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M49] | 2.3 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M49] | 8646.1 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M24] | 3.8 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M24] | 50.2 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M24] | 77.7 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M24] | 58.1 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M24] | 5 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M24] | 2.2 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M24] | 2 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M24] | 10.4 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M48] | 4.9 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M48] | 32 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M48] | 47.1 Titres |
| Nimenrix Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M48] | 29.8 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenY [M48] | 4.4 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenA [M48] | 2.9 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenW-135 [M48] | 2.6 Titres |
| Meningitec Group Y2 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres | hSBA-MenC [M48] | 11.3 Titres |
Secondary
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
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented, and with their symptom sheet filled-in.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Adverse Events (AEs) | 106 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Adverse Events (AEs) | 18 Participants |
Secondary
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
Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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
Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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
Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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
Population: The analysis was performed on the Total cohort for each persistence time point, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], who came back to the visit at the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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)
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 2 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
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
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented, and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any loss of appetite | 31 Participants |
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any drowsiness | 41 Participants |
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any temperature (orally, ≥ 37.5°C) | 16 Participants |
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any irritability | 40 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any temperature (orally, ≥ 37.5°C) | 1 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any irritability | 11 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any loss of appetite | 8 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited General Symptoms | Any drowsiness | 10 Participants |
Secondary
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
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary study (109670) \[NCT00474266\], with a booster vaccine administration documented and with their symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any pain | 149 Participants |
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness | 90 Participants |
| Nimenrix Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling | 70 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any pain | 23 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any Redness | 17 Participants |
| Meningitec Group Y2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any Swelling | 11 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 0.3 | 50 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 2.0 | 9 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 0.3 | 21 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 2.0 | 0 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 0.3 | 55 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 2.0 | 8 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 0.3 | 73 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 2.0 | 26 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 0.3 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 0.3 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 2.0 | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 0.3 | 1 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 0.3 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 2.0 | 0 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 0.3 | 128 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 2.0 | 27 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 0.3 | 37 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 2.0 | 2 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 0.3 | 117 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 2.0 | 13 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 0.3 | 102 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 2.0 | 19 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 2.0 | 1 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 0.3 | 20 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 0.3 | 11 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 2.0 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 0.3 | 19 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 0.3 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 2.0 | 1 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 0.3 | 53 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 2.0 | 26 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 0.3 | 16 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 2.0 | 3 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 0.3 | 56 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 2.0 | 5 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 0.3 | 48 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 2.0 | 7 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 2.0 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 0.3 | 20 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 0.3 | 17 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M48], ≥ 2.0 | 9 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M48], ≥ 0.3 | 18 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 0.3 | 7 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M48], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M48], ≥ 2.0 | 3 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M24], ≥ 2.0 | 8 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M24], ≥ 0.3 | 50 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M24], ≥ 0.3 | 25 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M24], ≥ 2.0 | 0 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M24], ≥ 0.3 | 56 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M24], ≥ 2.0 | 8 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M24], ≥ 0.3 | 72 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M24], ≥ 2.0 | 25 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M24], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M24], ≥ 2.0 | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M24], ≥ 0.3 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M24], ≥ 0.3 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M24], ≥ 0.3 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M24], ≥ 0.3 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M24], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M24], ≥ 2.0 | 0 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 0.3 | 61 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 2.0 | 10 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 0.3 | 28 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 2.0 | 0 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 0.3 | 68 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 2.0 | 11 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 0.3 | 89 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 2.0 | 33 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 0.3 | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 0.3 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M36], ≥ 2.0 | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M36], ≥ 0.3 | 1 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 0.3 | 4 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M36], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M36], ≥ 2.0 | 0 Participants |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSA [M49], ≥ 0.3 | 67 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSA [M49], ≥ 2.0 | 66 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSC [M49], ≥ 0.3 | 70 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSC [M49], ≥ 2.0 | 67 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSW-135 [M49], ≥ 0.3 | 69 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSW-135 [M49], ≥ 2.0 | 69 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSY [M49], ≥ 0.3 | 63 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSY [M49], ≥ 2.0 | 63 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSY [M49], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSA [M49], ≥ 0.3 | 15 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSW-135 [M49], ≥ 0.3 | 13 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSA [M49], ≥ 2.0 | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSY [M49], ≥ 0.3 | 9 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSC [M49], ≥ 0.3 | 18 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSW-135 [M49], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values | Anti-PSC [M49], ≥ 2.0 | 18 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M60], ≥ 0.3 | 98 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M60], ≥ 0.3 | 85 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M60], ≥ 2.0 | 98 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M60], ≥ 2.0 | 82 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M60], ≥ 0.3 | 85 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M60], ≥ 2.0 | 38 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M60], ≥ 2.0 | 85 Participants |
| Nimenrix Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M60], ≥ 0.3 | 98 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M60], ≥ 2.0 | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M60], ≥ 2.0 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M60], ≥ 0.3 | 13 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSC [M60], ≥ 2.0 | 10 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M60], ≥ 0.3 | 8 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135 [M60], ≥ 2.0 | 0 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSY [M60], ≥ 0.3 | 12 Participants |
| Meningitec Group Y2 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values | Anti-PSA [M60], ≥ 0.3 | 22 Participants |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M49], ≥ 1:4 | 201 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M49], ≥ 1:8 | 201 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M49], ≥ 1:4 | 209 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M49], ≥ 1:8 | 209 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M49], ≥ 1:4 | 192 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M49], ≥ 1:8 | 192 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M49], ≥ 1:4 | 173 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M49], ≥ 1:8 | 173 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M49], ≥ 1:8 | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M49], ≥ 1:4 | 4 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M49], ≥ 1:4 | 1 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M49], ≥ 1:8 | 4 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M49], ≥ 1:4 | 6 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M49], ≥ 1:4 | 33 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M49], ≥ 1:8 | 1 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M49], ≥ 1:8 | 33 Participants |
Secondary
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.
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M60], ≥ 1:4 | 211 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M60], ≥ 1:8 | 211 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M60], ≥ 1:4 | 228 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M60], ≥ 1:8 | 228 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M60], ≥ 1:4 | 218 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M60], ≥ 1:8 | 218 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M60], ≥ 1:4 | 206 Participants |
| Nimenrix Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M60], ≥ 1:8 | 206 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M60], ≥ 1:8 | 10 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M60], ≥ 1:4 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M60], ≥ 1:4 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenA [M60], ≥ 1:8 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenY [M60], ≥ 1:4 | 10 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M60], ≥ 1:4 | 33 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenW-135 [M60], ≥ 1:8 | 5 Participants |
| Meningitec Group Y2 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values | hSBA-MenC [M60], ≥ 1:8 | 33 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenA [M60], ≥ 1:8 | 231 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenA [M60], ≥ 1:128 | 229 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenC [M60], ≥ 1:8 | 225 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenC [M60], ≥ 1:128 | 181 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenW-135 [M60], ≥ 1:8 | 231 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenW-135 [M60], ≥ 1:128 | 229 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenY [M60], ≥ 1:8 | 231 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenY [M60], ≥ 1:128 | 229 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenY [M60], ≥ 1:128 | 11 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenA [M60], ≥ 1:8 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenW-135 [M60], ≥ 1:8 | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenA [M60], ≥ 1:128 | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenY [M60], ≥ 1:8 | 11 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenC [M60], ≥ 1:8 | 45 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenW-135 [M60], ≥ 1:128 | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values | rSBA-MenC [M60], ≥ 1:128 | 40 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 88 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 34 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 91 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 134 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 9 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 10 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 7 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 12 Participants |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M49], ≥ 1:8 | 214 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M49], ≥ 1:128 | 214 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M49], ≥ 1:8 | 215 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M49], ≥ 1:128 | 215 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M49], ≥ 1:8 | 215 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M49], ≥ 1:128 | 215 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M49], ≥ 1:8 | 215 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M49], ≥ 1:128 | 215 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M49], ≥ 1:128 | 14 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M49], ≥ 1:8 | 9 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M49], ≥ 1:8 | 8 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M49], ≥ 1:128 | 8 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M49], ≥ 1:8 | 14 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M49], ≥ 1:8 | 43 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M49], ≥ 1:128 | 7 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M49], ≥ 1:128 | 43 Participants |
Secondary
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.
Time frame: At Month 24 post primary vaccination
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenA [M24] | 166 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenC [M24] | 90 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenW-135 [M24] | 171 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenY [M24] | 154 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenY [M24] | 20 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenA [M24] | 16 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenW-135 [M24] | 12 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off | rSBA-MenC [M24] | 14 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 175 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 97 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 177 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 163 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M48] | 25 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M48] | 22 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M48] | 17 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M48] | 18 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 60 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 23 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 87 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 75 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 3 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 2 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 3 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 207 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 115 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 211 Participants |
| Nimenrix Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 195 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenY [M36] | 26 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenA [M36] | 23 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenW-135 [M36] | 16 Participants |
| Meningitec Group Y2 | Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off | rSBA-MenC [M36] | 19 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | 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 | hSBA-MenA [M24], ≥ 1:4 | 46 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenA [M24], ≥ 1:8 | 42 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M24], ≥ 1:4 | 154 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M24], ≥ 1:8 | 152 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M24], ≥ 1:4 | 167 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M24], ≥ 1:8 | 164 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M24], ≥ 1:4 | 134 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M24], ≥ 1:8 | 134 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M24], ≥ 1:8 | 5 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M24], ≥ 1:4 | 2 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M24], ≥ 1:4 | 0 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M24], ≥ 1:8 | 0 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M24], ≥ 1:4 | 5 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M24], ≥ 1:4 | 11 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M24], ≥ 1:8 | 0 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M24], ≥ 1:8 | 10 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | 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 | hSBA-MenA [M48], ≥ 1:4 | 58 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenA [M48], ≥ 1:8 | 57 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M48], ≥ 1:4 | 154 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M48], ≥ 1:8 | 153 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M48], ≥ 1:4 | 134 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M48], ≥ 1:8 | 133 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M48], ≥ 1:4 | 85 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M48], ≥ 1:8 | 85 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M48], ≥ 1:8 | 6 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M48], ≥ 1:4 | 4 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M48], ≥ 1:4 | 2 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M48], ≥ 1:8 | 4 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M48], ≥ 1:4 | 6 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M48], ≥ 1:4 | 15 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M48], ≥ 1:8 | 2 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M48], ≥ 1:8 | 15 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group Y2 | 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 | hSBA-MenA [M36], ≥ 1:4 | 95 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenA [M36], ≥ 1:8 | 90 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M36], ≥ 1:4 | 204 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenC [M36], ≥ 1:8 | 198 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M36], ≥ 1:4 | 209 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenW-135 [M36], ≥ 1:8 | 209 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M36], ≥ 1:4 | 184 Participants |
| Nimenrix Group Y2 | 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 | hSBA-MenY [M36], ≥ 1:8 | 180 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M36], ≥ 1:8 | 6 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M36], ≥ 1:4 | 5 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M36], ≥ 1:4 | 2 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenA [M36], ≥ 1:8 | 4 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenY [M36], ≥ 1:4 | 6 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M36], ≥ 1:4 | 13 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenW-135 [M36], ≥ 1:8 | 2 Participants |
| Meningitec Group Y2 | 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 | hSBA-MenC [M36], ≥ 1:8 | 13 Participants |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 437.1 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 105.4 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 398.2 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 411.1 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 186.9 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 106.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 49.1 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 53.6 Titres |
Secondary
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
Population: The analysis was performed on the Booster According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M49] | 7173.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M49] | 4511.9 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M49] | 10949.7 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M49] | 4585.3 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M49] | 15 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M49] | 10.7 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M49] | 9.6 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M49] | 3718.4 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M60] | 978.9 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M60] | 226.4 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M60] | 1390.7 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M60] | 1071.1 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M60] | 13.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M60] | 5.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M60] | 4.7 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M60] | 320.9 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 19.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 9.8 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 24.9 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 22.3 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 5.7 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 5.2 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 4.9 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 5.7 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 415.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 104.2 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 372.4 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 405.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M36] | 169.1 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M36] | 102.3 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M36] | 39.7 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M36] | 58.5 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M24] | 420.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M24] | 98.1 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M24] | 396.9 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M24] | 396.6 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M24] | 151.3 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M24] | 90.6 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M24] | 42.2 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M24] | 53.5 Titres |
Secondary
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
Population: The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who were eligible to participate in the primary study (109670) \[NCT00474266\], who complied with the protocol requirements and who had available assay results for at least one tested antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 107.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 12.3 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 30.5 Titres |
| Nimenrix Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 36.2 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenY [M48] | 10.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenA [M48] | 18.4 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenW-135 [M48] | 8 Titres |
| Meningitec Group Y2 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres | rSBA-MenC [M48] | 13.5 Titres |