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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1161-3151 | Other Identifier | WHO |
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The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).
Objective:
All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants received a booster dose of Menactra vaccine approximately four years earlier |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Biological | No vaccine will be administered in this trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Pre-booster vaccination, 28 days, and 4 years post-booster vaccination |
| Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Pre-booster vaccination, 28 days and 4 years post-booster vaccination |
| Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Pre-booster, 28 Days and 4 years post-booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bardstown | Kentucky | 40004 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 110 participants who met all inclusion and none of the exclusion criteria were enrolled; 109 participants completed the trial.
Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects; Menactra Vaccine | Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| Woburn |
| Massachusetts |
| 01801 |
| United States |
| Niles | Michigan | 49120 | United States |
| Layton | Utah | 84041 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects; Menactra Vaccine | Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| 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 Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination. | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of participants | Pre-booster vaccination, 28 days, and 4 years post-booster vaccination |
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| Primary | Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of participants | Pre-booster vaccination, 28 days and 4 years post-booster vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination | Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement. | Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-booster, 28 Days and 4 years post-booster vaccination |
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Monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample).
As no vaccine was administered in this trial, monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample). No safety events were reported. This was an immunogenicity assessment involving participants of an earlier study MTA77 (NCT01442675).
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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 | All Subjects; Menactra Vaccine | Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093. | 0 | 110 | 0 | 110 |
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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 |
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| 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 |
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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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| Title | Measurements |
|---|---|
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| Serogroup C; Pre-booster (N=108) |
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| Serogroup C; 28 days post-booster (N=109) |
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| Serogroup C; 4 years post-booster (N=109) |
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| Serogroup Y; Pre-booster (N=108) |
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| Serogroup Y; 28 days post-booster (N=109) |
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| Serogroup Y; 4 years post-booster (N=109) |
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| Serogroup W-135; Pre-booster (N=108) |
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| Serogroup W-135; 28 days post-booster (N=109) |
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| Serogroup W-135; 4 years post-booster (N=109) |
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