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To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.
Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Group 1 | Experimental | Participants aged 2 to < 4 years |
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| Menactra® Group 2 | Experimental | Participants aged 4 to < 6 years |
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| Menactra® Group 3 | Active Comparator | Participants aged 6 to < 11 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate | Biological | 0.5 mL, 2 doses Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | 30 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | 30 days post-vaccination |
| Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® 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 |
|---|---|---|---|---|---|---|
| Jonesboro | Arkansas | 72401 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Group 1 | Participants aged 2 to less than 4 years who received 2 doses of vaccine |
| FG001 | Menactra® Group 2 | Participants aged 4 to less than 6 years who received 2 doses of vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate | Biological | 0.5 mL, 2 doses Intramuscular |
|
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| Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate | Biological | 0.5 mL, 1 dose Intramuscular |
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Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) |
| 30 days post-vaccination |
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | 7 days post-vaccination 1 |
| Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | 7 days post-vaccination 2 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Boca Raton | Florida | 33433 | United States |
| Viera | Florida | 32940 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Las Vegas | Nevada | 89102 | United States |
| Cleveland | Ohio | 44121 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Charleston | South Carolina | 29425 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Antonio | Texas | 78205 | United States |
| Orem | Utah | 84057 | United States |
| Midlothian | Virginia | 23113 | United States |
| Spokane | Washington | 99202 | United States |
| FG002 | Menactra® Group 3 | Participants aged 6 to less than 11 years who received a single dose of vaccine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Group 1 | Participants aged 2 to less than 4 years who received 2 doses of vaccine |
| BG001 | Menactra® Group 2 | Participants aged 4 to less than 6 years who received 2 doses of vaccine |
| BG002 | Menactra® Group 3 | Participants aged 6 to less than 11 years who received a single dose of vaccine |
| BG003 | 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 Meningococcal Antibody Titers ≥ 8 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population. | Posted | Number | Percentage of Participants | 30 days post-vaccination |
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| Secondary | Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population. | Posted | Number | Percentage of Participants | 30 days post-vaccination |
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| Secondary | Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. | Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC) | Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 days post-vaccination |
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| Secondary | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population. | Posted | Number | Percentage of Participants | 7 days post-vaccination 1 |
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| Secondary | Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination | Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population. | Posted | Number | Percentage of Participants | 7 days post-vaccination 2 |
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Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 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 1 | Participants aged 2 to less than 4 years who received 2 doses of vaccine | 4 | 111 | 58 | 111 | ||
| EG001 | Menactra® Group 2 | Participants aged 4 to less than 6 years who received 2 doses of vaccine | 3 | 111 | 57 | 111 | ||
| EG002 | Menactra® Group 3 | Participants aged 6 to less than 11 years who received a single dose of vaccine | 0 | 111 | 64 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Breath holding | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site erythma | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Anorexia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-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 |
| 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 C Post-dose 1 ≥ 8 [n = 82, 89, 108] |
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| Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0] |
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| Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108] |
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| Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0] |
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| Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108] |
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| Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0] |
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