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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-18 years | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal ACWY conjugate vaccine | Biological | All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Overall 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 seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as:
| Day 1 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as:
|
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Inclusion Criteria:
Exclusion Criteria:
Individuals not eligible to be enrolled in the study were those:
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| Name | Affiliation | Role |
|---|---|---|
| Li Min Huang, Dr. | Dr. Li Min Huang, National Taiwan University Hospital | Principal Investigator |
| Nan Chang Chiu, Dr. | Mackay Memorial Hospital | Principal Investigator |
| Shu Jen Yeh, Dr. | Far Eastern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital, | Taipei | Taiwan | 10002 | China | ||
| National Taiwan University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25075804 | Derived | Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 Jul 27. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at three study centres in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-10 Years | Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
| FG001 | 11-18 Years | Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was done on all the enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-10 Years | Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
| BG001 | 11-18 Years | Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Overall 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 seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as:
| Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29. | Posted | Number | 95% Confidence Interval | Percentages of Subjects | Day 1 and Day 29 |
|
Throughout the study period (from day 1 through day 29)
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is equivalent to an event that was not solicited by the diary card.
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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 | 2-10 Years | Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| ID | Term |
|---|---|
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Day 1 and Day 29 |
| Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. | Day 1 and 29 |
| Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. | Day 1 and Day 29 |
| Percentage 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, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall. | Day 1 and 29 |
| Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination. | From day 1 through day 7 postvaccination |
| Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination. | From day 1 through day 7 postvaccination |
| Taipei |
| Taiwan |
| 10002 |
| China |
| Far Eastern Memorial Hospital, | Taipei | Taiwan | 22060 | China |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Overall (2 to 18 Years) |
Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
|
|
| Secondary | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as:
| Analysis was done on MITT population | Posted | Number | 95% Confidence Interval | Percentages of Subjects | Day 1 and Day 29 |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. | Analysis was done on MITT population | Posted | Geometric Mean | 95% Confidence Interval | hSBA Titers | Day 1 and 29 |
|
|
|
| Secondary | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. | Analysis was done on MITT population | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 and Day 29 |
|
|
|
| Secondary | Percentage 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, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall. | Analysis was done on MITT population | Posted | Number | 95% Confidence Interval | Percentages of Subjects | Day 1 and 29 |
|
|
|
| Secondary | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 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 | From day 1 through day 7 postvaccination |
|
|
|
| Secondary | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination. | Analysis was done on safety population. | Posted | Number | Subjects | From day 1 through day 7 postvaccination |
|
|
|
| 1 |
| 173 |
| 110 |
| 173 |
| EG001 | 11-18 Years | Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | 0 | 167 | 98 | 167 |
| EG002 | Overall (2 to 18 Years) | Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | 1 | 340 | 208 | 340 |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| MenW (N=168,166) |
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| MenY (N=167,166) |
|
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| MenC at Day 1 (N=167,166,333) |
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| MenC at Day 29 (N=167,166,333) |
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| MenW at Day 1 (N=168,166,334) |
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| MenW at Day 29 (N=168,166,334) |
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| MenY at Day 1 (N=167,166,333) |
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| MenY at Day 29 (N=167,166,333) |
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| MenW (N=168,166,334) |
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| MenY (N=167,166,333) |
|
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| MenC at Day 1 (N=167,166,333) |
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| MenC at Day 29 (N=167,166,333) |
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| MenW at Day 1 (N=168,166,334) |
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| MenW at Day 29 (N=168,166,334) |
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| MenY at Day 1 (N=167,166,333) |
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| MenY at Day 29 (N=167,166,333) |
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| Title | Measurements |
|---|---|
|
| Change in eating habits |
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| Sleepiness |
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| Irritability |
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| Vomiting |
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| Diarrhea |
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| Rash - Any |
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| Rash - Urticarial |
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| Fever (≥38°C) |
|
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| Injection site induration |
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| Chills |
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| Nausea |
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| Malaise |
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| Myalgia |
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| Arthralgia |
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| Headache |
|
| Rash - Any |
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| Rash - Urticarial |
|
| Fever (≥38°C) |
|