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The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Group 1 | Experimental | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination. |
|
| Menactra® Group 2 | Experimental | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination. |
|
| Meningococcal Vaccine-naïve Group 3 | Experimental | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. |
|
| Meningococcal Vaccine-naïve Group 4 | Experimental | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination. | 7 or 14 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 |
|---|---|---|---|---|---|---|
| Jonesboro | Arkansas | 72401 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.
Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Group 1 | Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination |
| FG001 | Menactra® Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Marietta | Georgia | 30062 | United States |
| Baltimore | Maryland | 21201-1559 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Bridgeton | Missouri | 63044 | United States |
| Rochester | New York | 14620 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Salt Lake City | Utah | 84123 | United States |
| Norfolk | Virginia | 23510 | United States |
Participants received Menactra® in Study 603-02.
Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination
| FG002 | Meningococcal Vaccine-naïve Group 3 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. |
| FG003 | Meningococcal Vaccine-naïve Group 4 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Group 1 | Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination |
| BG001 | Menactra® Group 2 | Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination |
| BG002 | Meningococcal Vaccine-naïve Group 3 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. |
| BG003 | Meningococcal Vaccine-naïve Group 4 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® 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 |
| |||||||||||||||
| 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 | Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination. | Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population. | Posted | Number | Percentage of participants | 7 or 14 days post-vaccination |
|
|
|
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 1 | Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination | 0 | 58 | 13 | 58 | ||
| EG001 | Menactra® Group 2 | Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination | 0 | 58 | 20 | 58 | ||
| EG002 | Meningococcal Vaccine-naïve Group 3 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. | 0 | 58 | 14 | 58 | ||
| EG003 | Meningococcal Vaccine-naïve Group 4 | Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination | 0 | 59 | 15 | 59 |
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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 |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Upper respiratory tract 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 |
|---|---|
| C052180 | Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate |
| 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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| Meningococcal serogroup A - POST |
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| Meningococcal serogroup C - PRE |
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| Meningococcal serogroup C - POST |
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| Meningococcal serogroup Y - PRE |
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| Meningococcal serogroup Y - POST |
|
| Meningococcal serogroup W-135 - PRE |
|
| Meningococcal serogroup W-135 - POST |
|