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The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Vaccine Group 1 | Experimental | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
|
| Menactra® Vaccine Group 2 | Experimental | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination |
|
| Meningococcal Vaccine-naive Group 3 | Active Comparator | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
|
| Meningococcal Vaccine-naive Group 4 | Active Comparator | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination. | 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | Day 0 to 7 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 |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | 30322 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.
Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Vaccine Group 1 | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
| 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 |
|
|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
|
| Marietta |
| Georgia |
| 30062 |
| United States |
| Woburn | Massachusetts | 01801 | United States |
| Akron | Ohio | 44308 | United States |
| Columbus | Ohio | 43205 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Norfolk | Virginia | 23510 | United States |
| FG001 |
| Menactra® Vaccine Group 2 |
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| FG002 | Meningococcal Vaccine-naive Group 3 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination |
| FG003 | Meningococcal Vaccine-naive Group 4 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Vaccine Group 1 | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. |
| BG001 | Menactra® Vaccine Group 2 | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| BG002 | Meningococcal Vaccine-naive Group 3 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination |
| BG003 | Meningococcal Vaccine-naive Group 4 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
| BG004 | 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 |
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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 | Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. | Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination. | SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population. | Posted | Number | Participants | 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) |
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| Other Pre-specified | Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions | Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. | Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population | Posted | Number | Participants | Day 0 to 7 post-vaccination |
|
28 days post-booster or post-primary Menactra® 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® Vaccine Group 1 | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination. | 0 | 9 | 1 | 9 | ||
| EG001 | Menactra® Vaccine Group 2 | Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. | 0 | 18 | 5 | 18 | ||
| EG002 | Meningococcal Vaccine-naive Group 3 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination | 0 | 58 | 32 | 58 | ||
| EG003 | Meningococcal Vaccine-naive Group 4 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. | 0 | 60 | 23 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Venipuncture site bruise | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 7.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | 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 |
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| >=65 years |
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| Male |
|
| Meningococcal serogroup A - Day 28 |
|
| Meningococcal serogroup C - Day 0 |
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| Meningococcal serogroup C - Day 28 |
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| Meningococcal serogroup Y - Day 0 |
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| Meningococcal serogroup Y - Day 28 |
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| Meningococcal serogroup W-135 - Day 0 |
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| Meningococcal serogroup W-135 - Day 28 |
|
| OG003 | Meningococcal Vaccine-naive Group 4 | Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination. |
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