Meningococcal Disease
Conditions
Keywords
Prevention of Meningococcal disease
Brief summary
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
Interventions
BIOLOGICALMenACWY-CRM197
Blood test, 40-months and 60-months children
BIOLOGICALBlood test
Blood test, 40-months and 60-months children
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Months to 63 Months
Healthy volunteers
Yes
Inclusion criteria
* Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health * Control subjects: healthy 60 months old who had received a complete MenC immunization course
Exclusion criteria
* Subjects with any serious, acute or chronic progressive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA ≥1:8 | At 40 and 60 months of age | Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA ≥1:4 | At 40 and 60 months of age | Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects. |
| GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | At 40 and 60 months of age | The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center. |
Countries
Canada, United Kingdom
Participant flow
Recruitment details
Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).
Participants by arm
| Arm | Count |
|---|---|
| UK2,3,4,12+ UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age. | 40 |
| UK2,4,12+ UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age. | 44 |
| UK2,4C/12+ UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age. | 22 |
| UK2,4,12- UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age. | 37 |
| UK Control Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination. | 43 |
| Ca2,4,6+ Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination. | 31 |
| Ca2,4,6+/12PS Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age | 26 |
| Ca2,4,12+ Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age. | 27 |
| Ca2,4+/12PS Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age. | 28 |
| Ca2,4,12- Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age. | 27 |
| Ca2,4-/12PS Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune \[1/5 dose\]) at 12 months of age. | 27 |
| Ca Control Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age. | 30 |
| Total | 382 |
Baseline characteristics
| Characteristic | Total | Ca Control | Ca2,4-/12PS | UK2,3,4,12+ | Ca2,4,12- | Ca2,4+/12PS | UK2,4,12+ | Ca2,4,12+ | Ca2,4,6+/12PS | Ca2,4,6+ | UK Control | UK2,4,12- | UK2,4C/12+ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 40 months (N=36,37,19,34,0,28,23,27,28,25,26,0) | 34.78 months STANDARD_DEVIATION 0.31 | NA months | 41.0 months STANDARD_DEVIATION 1.1 | 42.4 months STANDARD_DEVIATION 0.7 | 40.7 months STANDARD_DEVIATION 1 | 41.6 months STANDARD_DEVIATION 1 | 42.6 months STANDARD_DEVIATION 0.6 | 42 months STANDARD_DEVIATION 0.9 | 41.8 months STANDARD_DEVIATION 1.2 | 42 months STANDARD_DEVIATION 1 | NA months | 40.6 months STANDARD_DEVIATION 0.8 | 42.6 months STANDARD_DEVIATION 0.5 |
| Age, Customized 60 months (N=4,7,3,3,43,3,3,0,0,2,1,30) | 60.88 months STANDARD_DEVIATION 0.16 | 60.6 months STANDARD_DEVIATION 0.6 | 60.0 months STANDARD_DEVIATION 0 | 61.3 months STANDARD_DEVIATION 1 | 60.5 months STANDARD_DEVIATION 0.7 | NA months | 61.3 months STANDARD_DEVIATION 0.5 | NA months | 61.3 months STANDARD_DEVIATION 0.6 | 60.3 months STANDARD_DEVIATION 0.6 | 61.9 months STANDARD_DEVIATION 0.3 | 61.7 months STANDARD_DEVIATION 0.6 | 61.0 months STANDARD_DEVIATION 1 |
| Sex/Gender, Customized Female 40 months | 145 Number of subjects | NA Number of subjects | 14 Number of subjects | 14 Number of subjects | 12 Number of subjects | 10 Number of subjects | 19 Number of subjects | 15 Number of subjects | 9 Number of subjects | 19 Number of subjects | NA Number of subjects | 19 Number of subjects | 14 Number of subjects |
| Sex/Gender, Customized Female 60 months | 49 Number of subjects | 15 Number of subjects | 0 Number of subjects | 1 Number of subjects | 1 Number of subjects | NA Number of subjects | 4 Number of subjects | NA Number of subjects | 3 Number of subjects | 2 Number of subjects | 20 Number of subjects | 2 Number of subjects | 1 Number of subjects |
| Sex/Gender, Customized Male 40 months | 138 Number of subjects | NA Number of subjects | 12 Number of subjects | 22 Number of subjects | 13 Number of subjects | 18 Number of subjects | 18 Number of subjects | 12 Number of subjects | 14 Number of subjects | 9 Number of subjects | NA Number of subjects | 15 Number of subjects | 5 Number of subjects |
| Sex/Gender, Customized Male 60 months | 50 Number of subjects | 15 Number of subjects | 1 Number of subjects | 3 Number of subjects | 1 Number of subjects | NA Number of subjects | 3 Number of subjects | NA Number of subjects | 0 Number of subjects | 1 Number of subjects | 23 Number of subjects | 1 Number of subjects | 2 Number of subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 33 | 3 / 33 | 3 / 16 | 2 / 29 | 0 / 26 | 1 / 28 | 1 / 25 | 3 / 24 | 1 / 26 | 2 / 22 | 1 / 25 | 0 / 23 |
| serious Total, serious adverse events | 1 / 33 | 1 / 33 | 0 / 16 | 3 / 29 | 0 / 26 | 1 / 28 | 0 / 25 | 0 / 24 | 0 / 26 | 0 / 22 | 1 / 25 | 0 / 23 |
Outcome results
Primary
Percentage of Subjects With hSBA ≥1:8
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Time frame: At 40 and 60 months of age
Population: Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 34 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 41 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 9 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 61 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 73 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 69 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 27 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 76 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 85 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 32 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 47 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 61 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 11 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 69 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 71 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 8 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 71 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 11 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 59 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 29 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 76 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 71 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 78 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 71 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 42 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 3 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 74 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 33 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 45 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 53 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 84 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 29 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 36 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 29 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 30 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 31 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 32 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 29 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 0 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 20 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 14 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 4 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 14 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 44 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 48 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 24 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 13 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 26 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 4 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 7 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 14 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 59 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 57 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 43 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 31 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 44 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 24 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 43 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 22 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 4 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 21 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 35 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 0 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 42 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 64 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 57 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 72 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 81 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 27 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 38 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 4 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 8 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 0 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 57 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 63 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 46 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 58 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 67 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 46 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 53 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 10 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 3 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 34 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:8 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
Secondary
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
Time frame: At 40 and 60 months of age
Population: The analysis was done on MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 23 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 11 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3.75 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 6.43 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 18 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.6 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 22 Titers |
| UK2,3,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 4.98 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.58 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 4.69 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 35 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.69 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 27 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 17 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 15 Titers |
| UK2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 7.02 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 14 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.85 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 23 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 34 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 16 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 4.33 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 27 Titers |
| UK2,4C/12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 22 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.08 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 9.33 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 26 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.11 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 7.24 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 4.29 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 6.77 Titers |
| UK2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 26 Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 4.36 Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 6.51 Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2 Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 3.93 Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| UK Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3.86 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 5.24 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 3.18 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 3.77 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.01 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.08 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 2.75 Titers |
| Ca2,4,6+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 5.54 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 7.26 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.17 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 4.49 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 2.68 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 4.3 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 6.77 Titers |
| Ca2,4,6+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 2.86 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 12 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 4.17 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.56 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.37 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 3.22 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 10 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 6.44 Titers |
| Ca2,4,12+ | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 7.41 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 4.02 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 7.55 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 3.73 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.11 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 7.02 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 5.45 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.2 Titers |
| Ca2,4+/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3.96 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 13 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 4.85 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 24 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 11 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.36 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 23 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2.41 Titers |
| Ca2,4,12- | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 4.98 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 16 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 6.27 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 6.45 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 2 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 11 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 19 Titers |
| Ca2,4-/12PS | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 11 Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 2.82 Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.24 Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 9.46 Titers |
| Ca Control | GMTs in Subjects Within Each Site and in Age-Matched Control Subjects | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 5.02 Titers |
Secondary
Percentage of Subjects With hSBA ≥1:4
Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Time frame: At 40 and 60 months of age
Population: The analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 73 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 69 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 50 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 73 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 15 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 47 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 76 Percentages of subjects |
| UK2,3,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 30 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 85 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 78 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 8 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 79 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 53 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 11 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 44 Percentages of subjects |
| UK2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 69 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 29 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 71 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 76 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 22 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 88 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 83 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 71 Percentages of subjects |
| UK2,4C/12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 71 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 3 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 55 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 85 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 71 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 84 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 42 Percentages of subjects |
| UK2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 52 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 39 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 33 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 40 Percentages of subjects |
| UK Control | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 24 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 20 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 0 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 31 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 50 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 29 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 4 Percentages of subjects |
| Ca2,4,6+ | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 48 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 29 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 4 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 52 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 14 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 52 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 35 Percentages of subjects |
| Ca2,4,6+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 40 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 61 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 63 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 57 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 11 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 59 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 38 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 9 Percentages of subjects |
| Ca2,4,12+ | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 32 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 54 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 43 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 54 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 50 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 48 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 4 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 7 Percentages of subjects |
| Ca2,4+/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 35 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 72 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 9 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 68 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 81 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 59 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 54 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 62 Percentages of subjects |
| Ca2,4,12- | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 8 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 61 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 0 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 71 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 58 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 67 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 54 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 63 Percentages of subjects |
| Ca2,4-/12PS | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 0 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 34 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 67 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 13 Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | NA Percentages of subjects |
| Ca Control | Percentage of Subjects With hSBA ≥1:4 | MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 7 Percentages of subjects |