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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-2028 | Other Identifier | WHO |
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The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea.
Primary Objective:
Secondary objectives:
All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination.
Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Group | Experimental | Participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) |
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| Tdap - Adacel® Group | Active Comparator | Participants will receive Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level. | 28 Days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution. | Day 0 (pre-vaccination) and 28 days post-vaccination |
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Inclusion Criteria:
If the subject or the subject's parent(s) or legal representative is illiterate, an independent witness is required to sign the consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon | Chung gu | South Korea | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 300 participants that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study
The study participants were enrolled from 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Group | Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) |
| FG001 | Tdap - Adacel® Group | Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed | Biological | 0.5 mL, Intramuscular |
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| Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution. | Day 0 (pre-vaccination) and 28 days post-vaccination |
| Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). | Day 0 (pre-vaccination) and 28 days post-vaccination |
| Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity. | Day 0 up to Day 28 post-vaccination |
| Gyeonggi-do |
| Dongan Gu Anyang |
| South Korea |
| Seoul | Dongdaemun gu | South Korea |
| Seoul | Seodaemun gu | South Korea |
| Seoul | Seongbuk gu | South Korea |
| Gyeonggi-do | Suwon | South Korea |
| Gangwon Do | Wonju | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Group | Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) |
| BG001 | Tdap - Adacel® Group | Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) |
| 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, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level. | Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set | Posted | Number | Percentage of participants | 28 Days post-vaccination |
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| Secondary | Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution. | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and 28 days post-vaccination |
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| Secondary | Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution. | Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and 28 days post-vaccination |
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| Secondary | Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination | Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). | Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and 28 days post-vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine | Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity. | Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set | Posted | Number | Participants | Day 0 up to Day 28 post-vaccination |
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Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
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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 | Menactra® Group | Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) | 0 | 200 | 92 | 200 | ||
| EG001 | Tdap - Adacel® Group | Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) | 0 | 100 | 76 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| D013745 | Tetanus Toxoid |
| C509326 | adacel |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014121 | Toxoids |
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| >=65 years |
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| Male |
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| Serogroup Y |
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| Serogroup W-135 |
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