A Phase 3 interventional study of MenACWY-CRM in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 4 sites in Russian Federation. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention
To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 198 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.
Individuals eligible for enrollment in this study were those:
Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and:
Who were in good health as determined by
Exclusion Criteria:
Individuals not eligible to be enrolled in the study were those:
Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines.
(Exception: Influenza vaccine might be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination).
Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
MenACWY-CRM
Biological: MenACWY-CRM
1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
Time frame: Day 29
Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
Time frame: Day 29
Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Time frame: Days 1 and 29
Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
Time frame: Days 1 and 29
Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
Time frame: Within days 1 through 7 postvaccination
Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
Time frame: Within days 1 through 7 postvaccination
Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
Time frame: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29
Subjects were enrolled at 5 centers in Russia
| Milestone | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|
| Started | 66 | 66 | 66 |
| Completed | 65 | 66 | 66 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29). The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA \<1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
| Percentage of subjects | Overall (≥2 Years) |
|---|---|
| MenA | 85 (79 to 90) |
| MenC | 74 (67 to 80) |
| MenW | 60 (53 to 67) |
| MenY | 83 (77 to 88) |
Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
| Percentage of subjects | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|
| MenA | 89 (78 to 95) | 89 (79 to 96) | 77 (65 to 86) |
| MenC | 69 (56 to 80) | 82 (70 to 90) | 71 (58 to 81) |
| MenW | 73 (60 to 83) | 51 (38 to 63) | 57 (44 to 69) |
| MenY | 77 (65 to 87) | 88 (77 to 95) | 85 (74 to 92) |
Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
| human serum bactericidal assay titer | Overall (≥2 Years) | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|---|
| MenA (Day 1) | 2.35 (2.17 to 2.55) | 2.17 (1.79 to 2.62) | 2.43 (2.01 to 2.93) | 2.61 (2.11 to 3.23) |
| MenA (Day 29) | 93 (73 to 119) | 67 (38 to 119) | 134 (77 to 233) | 76 (41 to 143) |
| MenC (Day 1) | 4.07 (3.45 to 4.8) | 3.16 (2.18 to 4.57) | 3.59 (2.5 to 5.15) | 6.68 (4.43 to 10) |
| MenC (Day 29) | 59 (43 to 81) | 28 (14 to 56) | 47 (24 to 92) | 112 (52 to 243) |
| MenW (Day 1) | 12 (9.42 to 15) | 7.93 (4.69 to 13) | 21 (13 to 36) | 13 (7.16 to 23) |
| MenW (Day 29) | 111 (89 to 139) | 94 (56 to 155) | 117 (72 to 191) | 143 (83 to 248) |
| MenY (Day 1) | 2.93 (2.61 to 3.28) | 3.02 (2.33 to 3.92) | 3.73 (2.89 to 4.82) | 2.74 (2.05 to 3.66) |
| MenY (Day 29) | 58 (46 to 74) | 32 (18 to 56) | 67 (39 to 115) | 80 (43 to 147) |
Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
| Percentage of Subjects | Overall (≥2 Years) | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|---|
| MenA (Day 1) | 6 (3 to 10) | 2 (0.04 to 9) | 5 (1 to 13) | 11 (4 to 21) |
| MenA (Day 29) | 89 (83 to 93) | 89 (78 to 95) | 92 (83 to 97) | 85 (74 to 92) |
| MenC (Day 1) | 26 (20 to 33) | 13 (6 to 23) | 17 (9 to 28) | 49 (37 to 62) |
| MenC (Day 29) | 84 (78 to 89) | 76 (63 to 86) | 86 (75 to 93) | 89 (79 to 96) |
| MenW (Day 1) | 57 (50 to 64) | 30 (19 to 43) | 71 (58 to 81) | 69 (57 to 80) |
| MenW (Day 29) | 97 (93 to 99) | 95 (87 to 99) | 98 (92 to 100) | 97 (89 to 100) |
| MenY (Day 1) | 16 (11 to 22) | 10 (4 to 20) | 15 (8 to 26) | 22 (12 to 33) |
| MenY (Day 29) | 88 (82 to 92) | 79 (67 to 88) | 94 (85 to 98) | 89 (79 to 96) |
Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
| Percentage of subjects | ≥2 to ≤5 Years | ≥2 to ≤3 Years |
|---|---|---|
| Tenderness | 41 | 39 |
| Erythema | 26 | 28 |
| Induration | 19 | 17 |
| Change in Eating Habits | 4 | 6 |
| Sleepiness | 33 | 28 |
| Irritability | 26 | 17 |
| Vomiting | 4 | 0 |
| Diarrhea | 11 | 11 |
| Rash | 4 | 6 |
| Fever (≥38 °C) | 4 | 6 |
| Use of analgesics/antipyretics | 7 | 0 |
Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
| Percentage of Subjects | Overall (≥6 Years) | ≥6 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|---|
| Pain | 48 | 42 | 50 | 50 |
| Erythema | 18 | 18 | 18 | 17 |
| Induration | 14 | 11 | 17 | 12 |
| Chills | 9 | 8 | 8 | 12 |
| Nausea | 8 | 3 | 11 | 8 |
| Malaise | 20 | 16 | 23 | 20 |
| Myalgia | 19 | 13 | 29 | 14 |
| Arthralgia | 9 | 3 | 11 | 11 |
| Headache | 25 | 18 | 27 | 27 |
| Rash | 2 | 3 | 0 | 5 |
| Fever (≥38 °C) | 3 | 5 | 3 | 2 |
| Use of analgesic/antipyretics | 11 | 18 | 9 | 9 |
Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
| percentage of subjects | Overall (≥2 Years) | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years |
|---|---|---|---|---|
| Any AEs(days 1 through 7) | 17 | 20 | 12 | 18 |
| At least possibly related AEs (days 1 through 7) | 10 | 3 | 9 | 18 |
| SAE(days 1 through 29) | 0 | 0 | 0 | 0 |
| At least possibly related SAE(days 1 through 29) | 0 | 0 | 0 | 0 |
| Medically attended AE(days 1 through 29) | 4 | 8 | 2 | 3 |
| Premature withdrawal due to AE(days 1 through 29) | 0 | 0 | 0 | 0 |
Collected over From day 1 through day 29. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ≥2 to ≤10 Years | — | 0/65 (0%) | 42/65 (64.6%) |
| ≥11 to ≤17 Years | — | 0/66 (0%) | 42/66 (63.6%) |
| ≥18 Years | — | 0/66 (0%) | 44/66 (66.7%) |
| Overall (≥2 Years) | — | 0/197 (0%) | 128/197 (65%) |
| Event | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years | Overall (≥2 Years) |
|---|---|---|---|---|
| Injection site painGeneral disorders | 27/65 | 33/66 | 33/66 | 93/197 |
| MyalgiaMusculoskeletal and connective tissue disorders | 5/65 | 19/66 | 9/66 | 33/197 |
| HeadacheNervous system disorders | 8/65 | 18/66 | 18/66 | 44/197 |
| MalaiseGeneral disorders | 6/65 | 15/66 | 13/66 | 34/197 |
| Injection site erythemaGeneral disorders | 12/65 | 13/66 | 10/66 | 35/197 |
| Injection site indurationGeneral disorders | 8/65 | 11/66 | 8/66 | 27/197 |
| SomnolenceNervous system disorders | 9/65 | 1/66 | 0/66 | 10/197 |
| ChillsGeneral disorders | 3/65 | 5/66 | 8/66 | 16/197 |
| IrritabilityGeneral disorders | 7/65 | 0/66 | 0/66 | 7/197 |
| NauseaGastrointestinal disorders | 1/65 | 7/66 | 5/66 | 13/197 |
| Age, Continuous(year) | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years | Total |
|---|---|---|---|---|
| Mean | 6.0 ± 2.7 | 13.8 ± 2.1 | 38.8 ± 12.5 | 19.6 ± 15.9 |
| Sex: Female, Male(Participants) | ≥2 to ≤10 Years | ≥11 to ≤17 Years | ≥18 Years | Total |
|---|---|---|---|---|
| FEMALE | 35 | 29 | 44 | 108 |
| MALE | 31 | 37 | 22 | 90 |
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