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This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novartis MenACWY Vaccine (19 to 55 Years) | Experimental | Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years |
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| Licensed polysaccharide vaccine | Active Comparator | Licensed meningococcal ACWY polysaccharide vaccine |
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| Licensed Conjugate Vaccine | Active Comparator | Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine |
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| Novartis MenACWY Vaccine (56 to 65 Years) | Experimental | Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal ACWY Polysaccharide Vaccine | Biological | One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects. | Days 1 to 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 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 |
|---|---|---|---|---|---|---|
| Buenos Aires, Argentina | Buenos Aires | C1406DGI | Argentina | |||
| Cali, Colombia; Bogota, Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20655261 | Result | Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22. |
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All subjects enrolled were included in the trial.
Subjects were enrolled at 3 centers in Argentina and Colombia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Novartis MenACWY Vaccine (19 to 55 Years) | One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. |
| FG001 | Novartis MenACWY Vaccine (56 to 65 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| MenACWY CRM (19 to 55 years) | Biological | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age. |
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| Meningococcal ACWY Conjugate Vaccine | Biological | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection. |
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| Novartis MenACWY Vaccine (56 to 65 Years) | Biological | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age. |
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| 1 month postvaccination |
| Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. | 1 month postvaccination |
| Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age. | 1 month postvaccination |
| Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age. | 1 month postvaccination |
| Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years). | Days 1 to 7 |
| Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years). | Days 1 to 7 |
| Cali; Bogota |
| Colombia |
One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. |
| FG002 | Licensed Conjugate Vaccine (19 to 55 Years) | One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years). |
| FG003 | Licensed Polysaccharide Vaccine (56 to 65 Years) | One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Novartis MenACWY Vaccine (19 to 55 Years) | One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. |
| BG001 | Novartis MenACWY Vaccine (56 to 65 Years) | One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution. |
| BG002 | Licensed Conjugate Vaccine (19 to 55 Years) | One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years). |
| BG003 | Licensed Polysaccharide Vaccine (56 to 65 Years) | One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Subjects |
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| 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 | Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years | Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects. | The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals. | Posted | Number | Subjects | Days 1 to 7 |
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| Secondary | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 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 | Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population | Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 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 | Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age. | 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 | Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population | Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age. | 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 | Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years | Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years). | The analysis was performed on the safety population. | Posted | Number | Subjects | Days 1 to 7 |
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| Secondary | Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years | Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years). | The analysis was done on the safety population. | Posted | Number | Subjects | Days 1 to 7 |
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Serious adverse events were collected from study day 1 to 180.
The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Novartis MenACWY Vaccine (19 to 55 Years) | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly. | 11 | 1,588 | 955 | 1,588 | ||
| EG001 | Novartis MenACWY Vaccine (56 to 65 Years) | One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly. | 1 | 216 | 124 | 216 | ||
| EG002 | Licensed Conjugate Vaccine (19 to 55 Years) | One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years. | 8 | 882 | 561 | 882 | ||
| EG003 | Licensed Polysaccharide Vaccine (56 to 65 Years) | One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years) | 1 | 109 | 62 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Generalised Oedema | General disorders | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
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| HIV Infection | Infections and infestations | Non-systematic Assessment |
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| Pelvic Inflammatory disease | Infections and infestations | Non-systematic Assessment |
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| Pyometra | Infections and infestations | Non-systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arthropod Sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Upper Limb Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Nephrectomy | Surgical and medical procedures | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
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| Hypovolaemic Shock | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment | N= 1588, 216, 882, 108 |
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| Chills | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@Novartis.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| Male |
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| Black |
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| Caucasian |
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| Hispanic |
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| Other |
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| Not Available |
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| Participants |
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