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| ID | Type | Description | Link |
|---|---|---|---|
| 11278 |
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To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM (1 dose) | Experimental | 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. |
|
| Licensed polysaccharide vaccine | Active Comparator | 1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 |
|
| MenACWY-CRM (2 doses) | Experimental | 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Investigational Reserach Program | Bentonville | Arkansas | 72712 | United States | ||
| Arkansas Pediatric Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20943209 | Result | Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29. |
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All subjects enrolled were included in the trial.
Participants were enrolled at 67 centers in the USA and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM (2 Doses) | 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age |
| FG001 | MenACWY-CRM (1 Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MenACWY-CRM | Biological | 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age |
|
|
| Licensed meningococcal ACWY vaccine | Biological | 1 injection of the licensed meningococcal ACWY was administered intramuscularly |
|
|
| 1 month postvaccination |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. | 1 month postvaccination |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. | 1 month postvaccination |
| Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. | 1 month postvaccination |
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets. | 1 month postvaccination |
| Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment. | Study days 1 to 7 |
| Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment. | Study days 1 to 7 |
| Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment. | day 1 to study termination (day 240) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Premier Health Research Center | Downey | California | 90241 | United States |
| Kaiser Permanente - Fremont | Fremont | California | 94538 | United States |
| Kaiser Permanente - Fresno | Fresno | California | 93726 | United States |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente - Pleasanton | Pleasanton | California | 94566 | United States |
| Kaiser Permanente - San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente - San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente - Aurora | Aurora | Colorado | 80012 | United States |
| 1st Allergy & Clinical Research | Centennial | Colorado | 80112 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| 1st Allergy & Clinical Research | Thornton | Colorado | 80233 | United States |
| Kaiser Permanente - Westminister | Westminister | Colorado | 80234 | United States |
| Kentucky Pediatric Research Center | Bardstown | Kentucky | 40004 | United States |
| Physicians to Children & Adolescents | Springfield | Kentucky | 40004 | United States |
| Benchmark Research | Metairie | Louisiana | 70006 | United States |
| St. Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| Meridian Clinical Research LLC | Omaha | Nebraska | 68134 | United States |
| Legacy Pediatrics | Rochester | New York | 14618 | United States |
| Duke University Medical Center | Durham | North Carolina | 27704 | United States |
| Durham Pediatrics | Durham | North Carolina | 27704 | United States |
| Regional Pediatric Associates PA | Durham | North Carolina | 27704 | United States |
| Odyssey Research | Fargo | North Dakota | 58103 | United States |
| Dr. Senders and Associates | Cleveland | Ohio | 44121 | United States |
| Calcagno Research & Development | Gresham | Oregon | 97030 | United States |
| Children's Health Care - West | Erie | Pennsylvania | 16505 | United States |
| University Of Pittsburgh Medical Center | Greenville | Pennsylvania | 16125 | United States |
| Family Healthcare Partners | Grove City | Pennsylvania | 16127 | United States |
| Pediatric Associates of Latrobe | Latrobe | Pennsylvania | 15650 | United States |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15217 | United States |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15220 | United States |
| South Hills Pediatrics | Pittsburgh | Pennsylvania | 15227 | United States |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15236 | United States |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15237 | United States |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15241 | United States |
| Laurel Pediatrics | Uniontown | Pennsylvania | 15401 | United States |
| Family Practice Medical Associates South | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Children's Community Pediatrics | Wexford | Pennsylvania | 15090 | United States |
| Jackson Clinic Professional Association | Jackson | Tennessee | 38305 | United States |
| Benchmark Research Ft. Worth | Fort Worth | Texas | 76135 | United States |
| Benchmark Research San Angelo | San Angelo | Texas | 76904 | United States |
| Jean Brown Research | Clinton | Utah | 84015 | United States |
| Wee Care Pediatrics | Layton | Utah | 84041 | United States |
| Cottonwood Pediatrics | Murray | Utah | 84107 | United States |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84121 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Copperview Medical Center | South Jordan | Utah | 84095 | United States |
| Rockwood Clinic | Spokane | Washington | 99202 | United States |
| Rockwood Clinic North | Spokane | Washington | 99218 | United States |
| TASC Research Services Inc. | Surrey | British Columbia | V3R 8P8 | Canada |
| Manitoba Clinic | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Clinical Trials Research Center | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Colchester Regional Hospital | Truro | Nova Scotia | B2N 1L2 | Canada |
| Albion Finch Medical Centre | Etobicoke | Ontario | M9V 4B4 | Canada |
| Medicor Research Inc. | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| Children's Hospital of Western Ontario | London | Ontario | N6A 1V2 | Canada |
| SKDS Research In. | Newmarket | Ontario | L3Y 5G8 | Canada |
| Herridge Community Health Clinic | Ottawa | Ontario | K1S 0G8 | Canada |
| Sarnia Institute of Clinical Research | Sarnia | Ontario | N7T 4X3 | Canada |
| Resolve Research Solutions | Toronto | Ontario | M5G 1N8 | Canada |
| Resolve Research Solutions | Toronto | Ontario | M5M 1B2 | Canada |
| Queen Elizabeth Hospital | Charlottetown | Prince Edward Island | C1A 8T5 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Commonwealth Medical Clinic | Mount Pearl | A1N 1W7 | Canada |
| White Hills Medical Clinic | St. John's | A1A 3R5 | Canada |
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1 |
| FG002 | Licensed Polysaccharide Vaccine | 1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM (2 Doses) | 2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age. |
| BG001 | MenACWY-CRM (1 Dose) | 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1. |
| BG002 | Licensed Polysaccharide Vaccine | 1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month postvaccination |
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| Secondary | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percenatage of subjects | 1 month postvaccination |
|
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| Primary | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month postvaccination |
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| Secondary | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | 1 month postvaccination |
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| Secondary | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. | The analysis was performed on the per-protocol (PP) population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month postvaccination |
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| Secondary | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month postvaccination |
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| Secondary | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. | The analysis was performed on the per-protocol (PP) population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month postvaccination |
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| Secondary | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month postvaccination |
|
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| Secondary | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | The analysis was performed on the per-protocol (PP) population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month postvaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets. | The analysis was performed on the per-protocol (PP) population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month postvaccination |
|
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| Secondary | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment. | The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported. | Posted | Number | Percentages of subjects | Study days 1 to 7 |
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| Secondary | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment. | The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported. | Posted | Number | Percenatage of subjects | Study days 1 to 7 |
|
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| Secondary | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment. | The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported. | Posted | Number | Percentage of Subjects | day 1 to study termination (day 240) |
|
|
All adverse events and serious adverse events were collectedfrom day 1 to study terminaton (day 240).
If the adverse event was solicited then the event is listed as systematic assessment. However, if the adverse event was not solicited (i.e., unsolicited), then the event is listed under non-systematic method of collection. Subjects not vaccinated were excluded from the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MenACWY-CRM (2 Doses) | 2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age | 2 | 351 | 253 | 351 | ||
| EG001 | MenACWY-CRM (1 Dose)_2 to 5 Years | 1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age. | 5 | 693 | 424 | 693 | ||
| EG002 | MenACWY-CRM (1 Dose)_6 to 10 Years | 1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age. | 3 | 582 | 340 | 582 | ||
| EG003 | Licensed Polysaccharide Vaccine_2 to 5 Years | 1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age. | 5 | 684 | 419 | 684 | ||
| EG004 | Licensed Polysaccharide Vaccine_6 to 10 Years | 1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age. | 2 | 571 | 342 | 571 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Mouth Cyst | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Parvovirus infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Peritonsillar Abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Shigella infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis Staphylococcal | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Adrenal Haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Pulmonary Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Psychiatric Symptom | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Bronchial Spasm | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| injection site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| irritablility | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| injection site induration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| mailaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| eating disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| rash | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@Novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
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| Serogroup W (N=594, 605) |
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| Serogroup Y (N=593, 600) |
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1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age. |
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| Licensed Polysaccharide Vaccine (6 to 10 Yoa) |
1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age |
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