A Phase 3 interventional study of MenACWY-CRM in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 11 sites in Germany. Open to participants aged 22 Months to 45 Months. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 205 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.
Children eligible to be enrolled in the study were those
Exclusion Criteria:
Main exclusion criteria:
Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Biological: MenACWY-CRM
Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Biological: MenACWY-CRM
Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Biological: MenACWY-CRM
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Time frame: 1 month post booster
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Time frame: 1 month post booster vaccination
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Time frame: 1 month after vaccination
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
Time frame: 1 month post vaccination
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Time frame: 1 month post vaccination
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time frame: 1 month post vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Time frame: Day 1-7 after vaccination
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Time frame: Day 1-28 after vaccination
Subjects for this extension study were enrolled from only sites in Germany that participated in the parent study.
| Milestone | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) + MenACWY (1 Booster Dose) |
|---|---|---|---|
| Started | 74 | 66 | 65 |
| Completed | 74 | 66 | 65 |
| Not completed | 0 | 0 | 0 |
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
| Percentages of subjects | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) |
|---|---|---|---|
| 13-33 months persistence (Serogroup A) | 13 (6 to 26) | 7 (2 to 20) | 0 (0 to 8) |
| 13-33 months persistence (Serogroup C)(N=52,40,42) | 27 (16 to 41) | 25 (13 to 41) | 36 (22 to 52) |
| 13-33 months persistence (Serogroup W-135) | 50 (36 to 64) | 63 (47 to 78) | 12 (4 to 25) |
| 13-33 months persistence (Serogroup Y) | 40 (27 to 55) | 39 (24 to 55) | 19 (8 to 33) |
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
| Titers | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) + MenACWY (1 Booster Dose) |
|---|---|---|---|
| 13-33 months persistence (Serogroup A) | 2.82 (2.36 to 3.37) | 2.52 (2.05 to 3.08) | 2 (1.64 to 2.43) |
| 13-33 months persistence (Serogroup C) N=52,40 | 3.94 (2.92 to 5.3) | 3.93 (2.79 to 5.53) | 4.94 (3.55 to 6.86) |
| 13-33 months persistence (Serogroup W-135) | 9.36 (6.31 to 14) | 12 (7.53 to 18) | 2.81 (1.82 to 4.32) |
| 13-33 months persistence (Serogroup Y) | 6.79 (4.87 to 9.47) | 6.03 (4.14 to 8.78) | 2.99 (2.08 to 4.3) |
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
| Percentages of subjects | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) |
|---|---|---|
| Pre-booster (Serogroup A) | 13 (6 to 26) | 7 (2 to 20) |
| 1 month post booster (Serogroup A) | 96 (87 to 100) | 98 (87 to 100) |
| Pre-booster (Serogroup C) N=52,40 | 27 (16 to 41) | 25 (13 to 41) |
| 1 month post booster (Serogroup C) N=52,40 | 100 (93 to 100) | 100 (91 to 100) |
| Pre-booster (Serogroup W-135) | 50 (36 to 64) | 63 (47 to 78) |
| 1 month post booster (Serogroup W-135) | 100 (93 to 100) | 100 (91 to 100) |
| Pre-booster (Serogroup Y) | 40 (27 to 55) | 39 (24 to 55) |
| 1 month post booster (Serogroup Y) | 100 (93 to 100) | 100 (91 to 100) |
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
| Titers | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) |
|---|---|---|
| Pre-booster (Serogroup A) | 2.82 (2.35 to 3.38) | 2.52 (2.05 to 3.09) |
| 1 month post booster (Serogroup A) | 182 (118 to 281) | 214 (131 to 350) |
| Pre-booster (Serogroup C) N=52,40 | 3.92 (2.92 to 5.26) | 3.91 (2.79 to 5.48) |
| 1 month post booster (Serogroup C) N=52,40 | 541 (399 to 733) | 968 (682 to 1372) |
| Pre-booster (Serogroup W-135) | 9.37 (6.3 to 14) | 12 (7.51 to 18) |
| 1 month post booster (Serogroup W-135) | 799 (564 to 1133) | 1267 (854 to 1879) |
| Pre-booster (Serogroup Y) | 6.79 (4.86 to 9.5) | 6.04 (4.13 to 8.82) |
| 1 month post booster (Serogroup Y) | 650 (448 to 941) | 676 (444 to 1027) |
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
| Percentages of subjects | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) |
|---|---|
| Pre-vaccination (Serogroup A) | 0 (0 to 9) |
| 1 month post vaccination (Serogroup A) | 61 (45 to 76) |
| Pre-vaccination (Serogroup C) N=39 | 36 (21 to 53) |
| 1 month post vaccination (Serogroup C) N=39 | 100 (91 to 100) |
| Pre-vaccination (Serogroup W-135) | 12 (4 to 26) |
| 1 month post vaccination (Serogroup W-135) | 95 (83 to 99) |
| Pre-vaccination (Serogroup Y) | 20 (9 to 35) |
| 1 month post vaccination (Serogroup Y) | 95 (83 to 99) |
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
| Titers | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) |
|---|---|
| Pre-vaccination (Serogroup A) | 2 (1.63 to 2.45) |
| 1 month post vaccination (Serogroup A) | 20 (12 to 32) |
| Pre-vaccination (Serogroup C) N=39 | 4.83 (3.44 to 6.77) |
| 1 month post vaccination (Serogroup C) N=39 | 1530 (1077 to 2173) |
| Pre-vaccination (Serogroup W-135) | 2.82 (1.81 to 4.39) |
| 1 month post vaccination (Serogroup W-135) | 54 (37 to 80) |
| Pre-vaccination (Serogroup Y) | 3.05 (2.09 to 4.44) |
| 1 month post vaccination (Serogroup Y) | 54 (35 to 81) |
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
| Percentages of subjects | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) |
|---|---|---|
| hSBA ≥1:8(Serogroup A) | 98 (87 to 100) | 61 (45 to 76) |
| hSBA ≥1:8 (Serogroup C) N=40,39 | 100 (91 to 100) | 100 (91 to 100) |
| hSBA ≥1:8(Serogroup W-135) | 100 (91 to 100) | 95 (83 to 99) |
| hSBA ≥1:8 (Serogroup Y) | 100 (91 to 100) | 95 (83 to 99) |
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
| Titers | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) |
|---|---|---|
| 1 month post vaccination (Serogroup A) | 214 (131 to 350) | 20 (12 to 32) |
| 1 month post vaccination (Serogroup C) N=40,39 | 968 (682 to 1372) | 1530 (1077 to 2173) |
| 1 month post vaccination (Serogroup W-135) | 1267 (854 to 1879) | 54 (37 to 80) |
| 1 month post vaccination (Serogroup Y) | 676 (444 to 1027) | 54 (35 to 81) |
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
| Participants | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) + MenACWY (1 Booster Dose) |
|---|---|---|---|
| Any Solicited Local | 33 | 30 | 30 |
| Injection site pain | 10 | 15 | 13 |
| Injection site erythema | 14 | 17 | 15 |
| Injection site induration | 6 | 8 | 7 |
| Any Solicited Systemic | 28 | 18 | 25 |
| Arthralgia | 1 | 5 | 4 |
| Headache | 5 | 6 | 1 |
| Vomiting | 0 | 2 | 1 |
| Change in eating habits | 6 | 8 | 6 |
| Rash | 0 | 2 | 1 |
| Sleepiness | 10 | 13 | 10 |
| Fever (≥38°C) | 8 | 7 | 7 |
| Any other | 5 | 7 | 5 |
| Stayed at home | 4 | 5 | 2 |
| Analgesic Antipyretic Medication Used | 4 | 6 | 5 |
| Temperature (≥40°C) (N= 52,41,41) | 0 | 0 | 2 |
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
| Participants | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) + MenACWY (1 Booster Dose) |
|---|---|---|---|
| Any AE | 11 | 10 | 9 |
| At least possibly related AEs | 0 | 2 | 1 |
| Serious AE | 0 | 0 | 0 |
| AEs leading to premature withdrawal | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 |
Collected over Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | — | 0/53 (0%) | 33/53 (62.3%) |
| MenACWY (1 Primary + 1 Booster Dose) | — | 0/44 (0%) | 31/44 (70.5%) |
| MenC (1 Primary Dose) + MenACWY (1 Booster Dose) | — | 0/43 (0%) | 30/43 (69.8%) |
| Event | MenACWY (2 Primary + 1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) + MenACWY (1 Booster Dose) |
|---|---|---|---|
| Injection site erythemaGeneral disorders | 14/53 | 17/44 | 15/43 |
| Injection site painGeneral disorders | 10/53 | 15/44 | 13/43 |
| IrritabilityGeneral disorders | 12/53 | 8/44 | 14/43 |
| SomnolenceNervous system disorders | 10/53 | 13/44 | 10/43 |
| DiarrhoeaGastrointestinal disorders | 4/53 | 2/44 | 8/43 |
| Injection site indurationGeneral disorders | 6/53 | 8/44 | 7/43 |
| PyrexiaGeneral disorders | 8/53 | 8/44 | 7/43 |
| Eating disorderPsychiatric disorders | 6/53 | 8/44 | 6/43 |
| HeadacheNervous system disorders | 5/53 | 6/44 | 1/43 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/53 | 5/44 | 4/43 |
| Age, Continuous(months) | MenACWY (2 Primary +1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Total |
|---|---|---|---|---|
| Mean | 36.7 ± 5.3 | 37.4 ± 5.6 | 37.9 ± 5.3 | 37.3 ± 5.4 |
| Sex: Female, Male(Participants) | MenACWY (2 Primary +1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Total |
|---|---|---|---|---|
| Female | 34 | 30 | 37 | 101 |
| Male | 40 | 36 | 28 | 104 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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