A Phase 2 interventional study of MenACWY-CRM197 and Blood test in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 3 sites in 2 countries. Open to participants aged 40 Months to 63 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-24.
Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention
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.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 382 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blood test
Biological: MenACWY-CRM197
Blood test
Biological: Blood test
Blood test, 40-months and 60-months children
Blood test, 40-months and 60-months children
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
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
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
Participants were enrolled at 3 sites (1 site in the UK and 2 sites in Canada).
| Milestone | UK Site | UK Control | Canada Sites | Canada Control |
|---|---|---|---|---|
| Started | 143 | 43 | 166 | 30 |
| Completed | 120 | 43 | 151 | 29 |
| Not completed | 23 | 0 | 15 | 1 |
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.
| Percentages of subjects | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 27 (13 to 46) | 8 (2 to 22) | 29 (10 to 56) | 3 (0.074 to 15) | NA (NA to NA) | 0 (0 to 12) | 4 (0 to 22) | 7 (1 to 24) | 0 (0 to 12) | 8 (1 to 26) | 0 (0 to 14) | NA (NA to NA) |
| MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 9 (2 to 24) | 11 (3 to 27) | 11 (1 to 35) | 3 (0.082 to 17) | 0 (0 to 8) | 0 (0 to 13) | 0 (0 to 14) | 4 (0 to 22) | 4 (0 to 20) | 4 (0 to 22) | 0 (0 to 14) | 3 (0.084 to 17) |
| MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 41 (24 to 59) | 47 (30 to 65) | 71 (44 to 90) | 33 (18 to 52) | NA (NA to NA) | 20 (6 to 44) | 14 (3 to 35) | 31 (14 to 52) | 35 (17 to 56) | 38 (19 to 59) | 46 (26 to 67) | NA (NA to NA) |
| MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 34 (19 to 53) | 32 (17 to 51) | 59 (33 to 82) | 45 (27 to 64) | 29 (16 to 45) | 14 (3 to 36) | 13 (3 to 32) | 14 (3 to 35) | 24 (8 to 47) | 27 (11 to 50) | 46 (26 to 67) | 53 (34 to 72) |
| MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 73 (54 to 87) | 69 (52 to 84) | 71 (44 to 90) | 74 (56 to 87) | NA (NA to NA) | 29 (13 to 49) | 48 (27 to 69) | 59 (39 to 78) | 43 (24 to 63) | 72 (51 to 88) | 58 (37 to 78) | NA (NA to NA) |
| MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 69 (50 to 84) | 85 (69 to 95) | 78 (52 to 94) | 84 (66 to 95) | 36 (22 to 52) | 31 (14 to 52) | 44 (24 to 65) | 57 (34 to 77) | 42 (22 to 63) | 81 (58 to 95) | 67 (45 to 84) | 34 (18 to 54) |
| MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 76 (58 to 89) | 61 (43 to 77) | 76 (50 to 93) | 53 (35 to 70) | NA (NA to NA) | 32 (16 to 52) | 26 (10 to 48) | 44 (25 to 65) | 21 (8 to 41) | 64 (43 to 82) | 63 (41 to 81) | NA (NA to NA) |
| MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 61 (42 to 77) | 71 (53 to 85) | 71 (44 to 90) | 42 (25 to 61) | 29 (16 to 45) | 30 (14 to 50) | 24 (9 to 45) | 43 (23 to 66) | 22 (7 to 44) | 57 (34 to 78) | 57 (34 to 77) | 10 (2 to 27) |
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.
| Percentages of subjects | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 30 (16 to 49) | 8 (2 to 22) | 29 (10 to 56) | 3 (0.074 to 15) | NA (NA to NA) | 0 (0 to 12) | 4 (0 to 22) | 11 (2 to 29) | 7 (1 to 24) | 8 (1 to 26) | 0 (0 to 14) | NA (NA to NA) |
| MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 15 (5 to 32) | 11 (3 to 27) | 22 (6 to 48) | 3 (0.082 to 17) | 0 (0 to 8) | 4 (0.094 to 19) | 0 (0 to 14) | 9 (1 to 28) | 4 (0 to 20) | 9 (1 to 28) | 0 (0 to 14) | 7 (1 to 22) |
| MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 47 (29 to 65) | 53 (35 to 70) | 71 (44 to 90) | 42 (25 to 61) | NA (NA to NA) | 20 (6 to 44) | 14 (3 to 35) | 38 (20 to 59) | 54 (33 to 73) | 54 (33 to 74) | 54 (33 to 74) | NA (NA to NA) |
| MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 50 (32 to 68) | 44 (27 to 62) | 71 (44 to 90) | 52 (33 to 70) | 40 (26 to 57) | 24 (8 to 47) | 29 (13 to 51) | 32 (14 to 55) | 48 (26 to 70) | 59 (36 to 79) | 58 (37 to 78) | 67 (47 to 83) |
| MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 73 (54 to 87) | 69 (52 to 84) | 71 (44 to 90) | 85 (69 to 95) | NA (NA to NA) | 29 (13 to 49) | 52 (31 to 73) | 63 (42 to 81) | 54 (34 to 72) | 72 (51 to 88) | 71 (49 to 87) | NA (NA to NA) |
| MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29 | 69 (50 to 84) | 85 (69 to 95) | 83 (59 to 96) | 84 (66 to 95) | 39 (22 to 52) | 31 (14 to 52) | 52 (31 to 72) | 61 (39 to 80) | 50 (29 to 71) | 81 (58 to 95) | 67 (45 to 84) | 34 (18 to 54) |
| MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0 | 76 (58 to 89) | 78 (61 to 90) | 88 (64 to 99) | 71 (53 to 85) | NA (NA to NA) | 50 (31 to 69) | 35 (16 to 57) | 59 (39 to 78) | 43 (24 to 63) | 68 (46 to 85) | 63 (41 to 81) | NA (NA to NA) |
| MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30 | 73 (54 to 87) | 79 (62 to 91) | 76 (50 to 93) | 55 (36 to 73) | 33 (20 to 50) | 48 (29 to 68) | 40 (21 to 61) | 57 (34 to 77) | 35 (16 to 57) | 62 (38 to 82) | 61 (39 to 80) | 13 (4 to 31) |
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.
| Titers | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 3.75 (2.76 to 5.11) | 2.58 (1.93 to 3.45) | 4.33 (2.82 to 6.66) | 2.08 (1.54 to 2.82) | NA (NA to NA) | 2.01 (1.69 to 2.39) | 2.17 (1.79 to 2.39) | 2.56 (2.15 to 3.05) | 2.11 (1.77 to 2.5) | 2.41 (2.01 to 2.89) | 2 (1.66 to 2.4) | NA (NA to NA) |
| MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30 | 2.6 (2.12 to 3.19) | 2.69 (2.21 to 3.28) | 2.85 (2.16 to 3.75) | 2.11 (1.71 to 2.61) | 2 (1.67 to 2.39) | 2.08 (1.77 to 2.45) | 2 (1.69 to 2.36) | 2.37 (1.99 to 2.82) | 2.2 (1.86 to 2.6) | 2.36 (1.98 to 2.8) | 2 (1.69 to 2.37) | 2.24 (1.91 to 2.62) |
| MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0 | 6.43 (3.85 to 11) | 7.02 (4.33 to 11) | 23 (11 to 46) | 4.29 (2.59 to 7.11) | NA (NA to NA) | 3.18 (1.98 to 5.1) | 2.68 (1.71 to 4.2) | 4.17 (2.77 to 6.27) | 5.45 (3.62 to 8.2) | 4.98 (3.26 to 7.62) | 6.45 (4.22 to 9.86) | NA (NA to NA) |
| MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30 | 4.98 (3.28 to 7.55) | 4.69 (3.13 to 7.04) | 14 (8.15 to 26) | 6.77 (4.43 to 10) | 3.93 (2.73 to 5.65) | 2.75 (1.77 to 4.26) | 2.86 (1.9 to 4.3) | 3.22 (2.11 to 4.92) | 4.02 (2.6 to 6.21) | 4.85 (3.17 to 7.4) | 6.27 (4.18 to 9.41) | 9.46 (6.48 to 14) |
| MenW 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 23 (13 to 42) | 27 (15 to 47) | 22 (9.65 to 50) | 26 (14 to 46) | NA (NA to NA) | 3.86 (2.15 to 6.93) | 6.77 (3.55 to 13) | 12 (6.72 to 22) | 7.55 (4.22 to 14) | 23 (13 to 43) | 16 (8.63 to 30) | NA (NA to NA) |
| MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,30 | 18 (10 to 32) | 35 (20 to 60) | 34 (16 to 72) | 26 (15 to 45) | 6.51 (3.99 to 11) | 3.77 (2.14 to 6.64) | 7.26 (4.08 to 13) | 10 (5.77 to 19) | 7.02 (3.9 to 13) | 24 (13 to 45) | 19 (11 to 35) | 5.02 (2.88 to 8.73) |
| MenY 40mths N=33,37,17,34,0,28,23,27,28,25,24,0 | 22 (13 to 38) | 15 (9.16 to 26) | 27 (13 to 58) | 9.33 (5.48 to 16) | NA (NA to NA) | 5.54 (3.39 to 9.06) | 4.3 (2.49 to 7.4) | 7.41 (4.5 to 12) | 3.96 (2.42 to 6.46) | 13 (7.47 to 21) | 11 (6.2 to 18) | NA (NA to NA) |
| MenY 60mths N=33,34,17,31,42,28,25,23,23,21,23,30 | 11 (6.87 to 18) | 17 (10 to 27) | 16 (8.03 to 32) | 7.24 (4.35 to 12) | 4.36 (2.81 to 6.75) | 5.24 (3.32 to 8.27) | 4.49 (2.79 to 7.22) | 6.44 (3.94 to 11) | 3.73 (2.27 to 6.12) | 11 (6.57 to 18) | 11 (6.88 to 18) | 2.82 (1.8 to 4.42) |
Collected over Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UK2,3,4,12+ | — | 1/33 (3%) | 5/33 (15.2%) |
| UK2,4,12+ | — | 1/33 (3%) | 3/33 (9.1%) |
| UK2,4C/12+ | — | 0/16 (0%) | 3/16 (18.8%) |
| UK2,4,12- | — | 3/29 (10.3%) | 2/29 (6.9%) |
| UK Control | — | 0/26 (0%) | 0/26 (0%) |
| Ca2,4,6+ | — | 1/28 (3.6%) | 1/28 (3.6%) |
| Ca2,4,6+/12PS | — | 0/25 (0%) | 1/25 (4%) |
| Ca2,4,12+ | — | 0/24 (0%) | 3/24 (12.5%) |
| Ca2,4+/12PS | — | 0/26 (0%) | 1/26 (3.8%) |
| Ca2,4,12- | — | 0/22 (0%) | 2/22 (9.1%) |
| Ca2,4-/12PS | — | 1/25 (4%) | 1/25 (4%) |
| Ca Control | — | 0/23 (0%) | 0/23 (0%) |
| Event | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jaw fractureInjury, poisoning and procedural complications | 0/33 | 0/33 | 0/16 | 0/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 1/25 | 0/23 |
| Pneumonia streptococcalInfections and infestations | 0/33 | 0/33 | 0/16 | 0/29 | 0/26 | 1/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| PneumoniaInfections and infestations | 0/33 | 0/33 | 0/16 | 1/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Forearm fractureInjury, poisoning and procedural complications | 0/33 | 0/33 | 0/16 | 1/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Asperger's disorderPsychiatric disorders | 0/33 | 0/33 | 0/16 | 1/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Lower respiratory tract infectionInfections and infestations | 1/33 | 0/33 | 0/16 | 0/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Accidental overdoseInjury, poisoning and procedural complications | 0/33 | 1/33 | 0/16 | 0/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Event | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/33 | 0/33 | 0/16 | 0/29 | 0/26 | 0/28 | 0/25 | 3/24 | 0/26 | 0/22 | 1/25 | 0/23 |
| Otitis mediaInfections and infestations | 0/33 | 0/33 | 0/16 | 0/29 | 0/26 | 0/28 | 0/25 | 1/24 | 0/26 | 2/22 | 0/25 | 0/23 |
| H1N1 influenzaInfections and infestations | 3/33 | 1/33 | 0/16 | 0/29 | 0/26 | 1/28 | 1/25 | 0/24 | 1/26 | 0/22 | 0/25 | 0/23 |
| ImpetigoInfections and infestations | 0/33 | 0/33 | 1/16 | 1/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 1/22 | 1/25 | 0/23 |
| Lower respiratory tract infectionInfections and infestations | 2/33 | 2/33 | 1/16 | 0/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Head injuryInfections and infestations | 0/33 | 0/33 | 1/16 | 1/29 | 0/26 | 0/28 | 0/25 | 0/24 | 0/26 | 0/22 | 0/25 | 0/23 |
| Age, Customized(months) | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 40 months (N=36,37,19,34,0,28,23,27,28,25,26,0) | 42.4 ± 0.7 | 42.6 ± 0.6 | 42.6 ± 0.5 | 40.6 ± 0.8 | NA ± NA | 42 ± 1 | 41.8 ± 1.2 | 42 ± 0.9 | 41.6 ± 1 | 40.7 ± 1 | 41.0 ± 1.1 | NA ± NA | 34.78 ± 0.31 |
| 60 months (N=4,7,3,3,43,3,3,0,0,2,1,30) | 61.3 ± 1.0 | 61.3 ± 0.5 | 61.0 ± 1.0 | 61.7 ± 0.6 | 61.9 ± 0.3 | 60.3 ± 0.6 | 61.3 ± 0.6 | NA ± NA | NA ± NA | 60.5 ± 0.7 | 60.0 ± 0.0 | 60.6 ± 0.6 | 60.88 ± 0.16 |
| Sex/Gender, Customized(Number of subjects) | UK2,3,4,12+ | UK2,4,12+ | UK2,4C/12+ | UK2,4,12- | UK Control | Ca2,4,6+ | Ca2,4,6+/12PS | Ca2,4,12+ | Ca2,4+/12PS | Ca2,4,12- | Ca2,4-/12PS | Ca Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female 40 months | 14 | 19 | 14 | 19 | NA | 19 | 9 | 15 | 10 | 12 | 14 | NA | 145 |
| Male 40 months | 22 | 18 | 5 | 15 | NA | 9 | 14 | 12 | 18 | 13 | 12 | NA | 138 |
| Female 60 months | 1 | 4 | 1 | 2 | 20 | 2 | 3 | NA | NA | 1 | 0 | 15 | 49 |
| Male 60 months | 3 | 3 | 2 | 1 | 23 | 1 | 0 | NA | NA | 1 | 1 | 15 | 50 |
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