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This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naĂŻve children (Control Group). This study will evaluate the administration of MenactraÂź in terms of the serum bactericidal antibody it induces in the two study groups. Safety of MenactraÂź vaccine will be described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MenactraÂź Booster Group | Experimental | Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with MenactraÂź vaccine. |
|
| Group 2: MenactraÂź Primary Vaccine (Control) Group | Experimental | Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with MenactraÂź vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenactraÂź: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-MenactraÂź Vaccination. | Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination | |
| Percentage of Participants With â„ 4-Fold Rise in Titers for the MenactraÂź Vaccine Serogroups A, C, Y, and W-135. | Day 28 Post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With MenactraÂź | Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia. | Days 0-7 Post-vaccination |
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 |
|---|---|---|---|---|---|---|
| AlKhaleej | Al-Qassim Region | Saudi Arabia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22855388 | Derived | Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Johnson DR, Borrow R. Safety and immunogenicity of a meningococcal quadrivalent conjugate vaccine in five- to eight-year-old Saudi Arabian children previously vaccinated with two doses of a meningococcal quadrivalent polysaccharide vaccine. Clin Vaccine Immunol. 2012 Oct;19(10):1561-6. doi: 10.1128/CVI.00260-12. Epub 2012 Aug 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: MenactraÂź Booster Group | Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with MenactraÂź vaccine. |
| FG001 | Group 2: MenactraÂź Primary Vaccine (Control) Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MenactraÂź: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
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| AlRabwa |
| Al-Qassim Region |
| Saudi Arabia |
| S. Buraida | Al-Qassim Region | Saudi Arabia |
| Safra-Al Midhnab | Al-Qassim Region | Saudi Arabia |
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with MenactraÂź vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: MenactraÂź Booster Group | Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with MenactraÂź vaccine. |
| BG001 | Group 2: MenactraÂź Primary Vaccine (Control) Group | Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with MenactraÂź vaccine. |
| BG002 | 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 |
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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 | ||||||||||||||||||||||||||||||
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| Other Pre-specified | Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With MenactraÂź | Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population. | Posted | Number | Participants | Days 0-7 Post-vaccination |
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| Primary | Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-MenactraÂź Vaccination. | Geometric mean titers by serum bactericidal assay were determined in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With â„ 4-Fold Rise in Titers for the MenactraÂź Vaccine Serogroups A, C, Y, and W-135. | 4-Fold rise in MenactraÂź vaccine antibodies were evaluated in the per-protocol population. | Posted | Number | Percentage of Participants | Day 28 Post-vaccination |
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Adverse events data were collected from the day of vaccination for up to 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 | Group 1: MenactraÂź Booster Group | Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with MenactraÂź vaccine. | 1 | 151 | 32 | 151 | ||
| EG001 | Group 2: MenactraÂź Primary Vaccine (Control) Group | Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with MenactraÂź vaccine. | 0 | 85 | 15 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Postoperative wound infections | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA 9.0 | 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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| >=65 years |
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| Male |
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| Grade 3 Pain (Incapacitating) |
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| Any Erythema |
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| Grade 3 Erythema (â„ 5 cm) |
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| Any Swelling |
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| Grade 3 Swelling (â„ 5 cm) |
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| Any Solicited Systemic Reaction |
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| Any Fever |
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| Grade 3 Fever (> 39.0 ÂșC) |
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| Any Headache |
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| Grade 3 Headache (Prevents daily activities) |
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| Any Malaise |
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| Grade 3 Malaise (Prevents daily activities) |
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| Any Myalgia |
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| Grade 3 Myalgia (Prevents daily activities) |
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