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This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Group | Experimental | Received Menactra® vaccine in Study MTA02 |
|
| Menomune® Group | Experimental | Received Menomune® vaccine in Study MTA02 |
|
| Control Group | Experimental | Meningococcal vaccine-naïve Control Group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group. | Day 0 and 8 and 28 days post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | 30322 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16203934 | Result | Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005 Oct;159(10):907-13. doi: 10.1001/archpedi.159.10.907. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.
Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Group | Subjects that received Menactra® vaccine in Study MTA02 |
| FG001 | Menomune® Group | Subjects that received Menomune® vaccine in Study MTA02 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
|
| Marietta |
| Georgia |
| 30062 |
| United States |
| Woburn | Massachusetts | 01801 | United States |
| Albany | New York | 12208 | United States |
| Akron | Ohio | 44308 | United States |
| Columbus | Ohio | 43205 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Norfolk | Virginia | 23501 | United States |
| FG002 | Control Group | Meningococcal vaccine-naïve subjects |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Group | Subjects that received Menactra® vaccine in Study MTA02 |
| BG001 | Menomune® Group | Subjects that received Menomune® vaccine in Study MTA02 |
| BG002 | Control Group | Meningococcal vaccine-naïve subjects |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. | Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group. | GMT results were on the per-protocol population for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 0 and 8 and 28 days post-vaccination |
|
|
|
Adverse events data were collected from the day of vaccination for 28 days 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 | Subjects that received Menactra® vaccine in Study MTA02 | 0 | 76 | 7 | 76 | ||
| EG001 | Menomune® Group | Subjects that received Menomune® vaccine in Study MTA02 | 0 | 77 | 5 | 77 | ||
| EG002 | Control Group | Meningococcal vaccine-naïve subjects | 0 | 88 | 9 | 88 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
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 |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
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| Serogroup A (Day 28) |
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| Serogroup C (Day 0) |
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| Serogroup C (Day 8) |
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| Serogroup C (Day 28) |
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| Serogroup Y (Day 0) |
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| Serogroup Y (Day 8) |
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| Serogroup Y (Day 28) |
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| Serogroup W-135 (Day 0) |
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| Serogroup W-135 (Day 8) |
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| Serogroup W-135 (Day 28) |
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