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This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM | Experimental | Subjects received one dose of MenACWY-CRM conjugate vaccine. |
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| Placebo | Placebo Comparator | Subjects received the saline placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novartis MenACWY-CRM | Biological | All subjects had blood drawn at Day 1 and Day 29. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as:
| day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination). | day 1 and day 29 |
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Inclusion Criteria:
Individuals eligible for enrollment in this study were those:
who were 11-55 years of age inclusive and who, after the nature of the study had been explained:
who the investigator believed that they or their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
who were in good health as determined by
who had negative urine pregnancy test for women of childbearing age.
Exclusion Criteria:
Individuals not eligible to be enrolled in the study were those:
who were unwilling or unable to give written informed assent or consent to participate in the study.
who were perceived to be unreliable or unavailable for the duration of the study period.
who were planning to leave the area of the study site before the end of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
who had previously been immunized with a meningococcal vaccine.
who had received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
who had received any licensed 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 was administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
who had experienced within the 7 days prior to enrollment significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥38°C) within 3 days prior to enrollment.
who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
who had epilepsy or any progressive neurological disease.
who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components, including latex allergies.
who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Kosin University Gospel Hospital | Busan | South Korea | ||||
| Department of Pediatrics, Seoul National University Bundang Hospital |
All enrolled subjects were included in the trial.
Participants were enrolled at 8 centres in the Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM | Subjects received one dose of MenACWY-CRM conjugate vaccine. |
| FG001 | Placebo | Subjects received the saline placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Saline Placebo |
| Biological |
All subjects had blood drawn at Day 1 and Day 29. |
|
| Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination). | day 1 and day 29 |
| Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination | during 7 days of vaccination |
| Gyeonggi-do |
| South Korea |
| Deaprtment of Pediatrics, Inha University Hospital | Incheon | South Korea |
| Division of Infectious Diseases, Inha University Hospital | Incheon | South Korea |
| Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University | Kyunggi | South Korea |
| Department of Pediatrics, Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Division of Infection Diseases, Seoul National University Hospital | Seoul | South Korea |
| Division of Infectious Diseases, Korea University Guro Hospital | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM | Subjects received one dose of MenACWY-CRM conjugate vaccine. |
| BG001 | Placebo | Subjects received the saline placebo. |
| BG002 | 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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| 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 Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as:
| Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points. | Posted | Number | 95% Confidence Interval | Percentages of subjects | day 29 |
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| Secondary | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination). | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | day 1 and day 29 |
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| Secondary | Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination). | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentages of subjects | day 1 and day 29 |
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| Secondary | Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination | Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data. | Posted | Number | Subjects | during 7 days of vaccination |
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Throughout the study period (29 days)
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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 | MenACWY-CRM | Subjects received one dose of MenACWY-CRM conjugate vaccine. | 0 | 297 | 117 | 297 | ||
| EG001 | Placebo | Subjects received the saline placebo. | 0 | 153 | 50 | 153 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chills | General disorders | MedDRA | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Systematic Assessment |
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| Malaise | General disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System 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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| Serogroup W (N=293,151) |
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| Serogroup Y (N=294,152) |
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| The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%. | Clopper and Pearson | The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%. | Lower limit of the two-sided 95% CI | 82 | 2-Sided | 95 | 82 | 90 | For the serogroup C | No | Superiority or Other |
| The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%. | Clopper and Pearson | The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%. | Lower limit of the two-sided 95% CI | 23 | 2-Sided | 95 | 23 | 33 | For the serogroup W | No | Superiority or Other |
| The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%. | Clopper and Pearson | The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%. | Lower limit of the two-sided 95% CI | 63 | 2-Sided | 95 | 63 | 74 | For serogroup Y | No | Superiority or Other |
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