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Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.
Objectives:
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-Dose Menactra Group | Experimental | Participants received one dose of Menactra® in Study MTA26 |
|
| Two-Dose Menactra Group | Experimental | Participants received two doses of Menactra® in Study MTA26 |
|
| Menactra vaccine-naïve Group | Active Comparator | Participants had never received Menactra® vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal polysaccharide diphtheria toxoid conjugate | Biological | 0.5 mL, IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination. | Day 0 (pre-vaccination) and Day 30 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). | Day 0 (pre-vaccination) and Day 30 post-vaccination |
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 |
|---|---|---|---|---|---|---|
| Marietta | Georgia | 30062 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 181 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from 17 June 2008 to 01 October 2008 at 13 clinical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | One-Dose Menactra Group | Participants received one dose of Menactra® in Study MTA26. |
| FG001 | Two-Dose Menactra Group | Participants received two doses of Menactra® in Study MTA26. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Meningococcal polysaccharide diphtheria toxoid conjugate | Biological | 0.5 mL, IM |
|
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| Meningococcal polysaccharide diphtheria toxoid conjugate | Biological | 0.5 mL, IM |
|
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| Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® |
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours. |
| Day 0 up to Day 7 post-vaccination |
| Woodstock |
| Georgia |
| 30189 |
| United States |
| Bardstown | Kentucky | 40004 | United States |
| Annapolis | Maryland | 21401 | United States |
| Frederick | Maryland | 21702 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Greenville | Pennsylvania | 16125 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Pittsburgh | Pennsylvania | 15227 | United States |
| Pittsburgh | Pennsylvania | 15236 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Layton | Utah | 84041 | United States |
| Provo | Utah | 84604 | United States |
| FG002 | Menactra-naïve Group | Participants had never received Menactra® vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | One-Dose Menactra Group | Participants received one dose of Menactra® in Study MTA26. |
| BG001 | Two-Dose Menactra Group | Participants received two doses of Menactra® in Study MTA26 |
| BG002 | Menactra-naïve Group | Participants had never received Menactra® vaccine. |
| 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 | Months |
| |||||||||||||||
| 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 Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra® | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination. | Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set. | Posted | Number | Percentage of participants | Day 0 (pre-vaccination) and Day 30 post-vaccination |
|
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| Other Pre-specified | Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®. | Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). | Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilutions) | Day 0 (pre-vaccination) and Day 30 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours. | Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Percentage of participants | Day 0 up to Day 7 post-vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 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 | One-Dose Menactra Group | Participants received one dose of Menactra® in Study MTA26. | 0 | 48 | 26 | 48 | ||
| EG001 | Two-Dose Menactra Group | Participants received two doses of Menactra® in Study MTA26. | 0 | 66 | 43 | 66 | ||
| EG002 | Menactra-naïve Group | Participants had never received Menactra® vaccine. | 0 | 67 | 41 | 67 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Injection-site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection-site Erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection-site Swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | 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 |
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| >=65 years |
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| Male |
|
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| Serogroup A; Day 30, ≥1:4 (n=40, 62, 59) |
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| Serogroup A; Day 30, ≥1:8 (n=40, 62, 59) |
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| Serogroup C; Day 0, ≥1:4 (n=41, 63, 61) |
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| Serogroup C; Day 0, ≥1:8 (n=41, 63, 61) |
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| Serogroup C; Day 30, ≥1:4 (n=41, 63, 59) |
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| Serogroup C; Day 30, ≥1:8 (n=41, 63, 59) |
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| Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61) |
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| Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61) |
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| Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60) |
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| Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60) |
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| Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61) |
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| Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61) |
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| Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60) |
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| Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60) |
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Participants had never received Menactra® vaccine.
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