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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5608 | Other Identifier | WHO |
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The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.
Primary Objectives:
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test. | Baseline and 21 days post-vaccination |
| Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Day 0 and Day 30 post-vaccination |
| Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Day 0 to 30 post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia | Day 0 to 7 post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
Temporary contraindications delaying vaccination until resolved:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangalore | 560070 | India | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Age 2 to 11 Years Group | Participants at age 2 to 11 years on enrollment. |
| FG001 | Age 12 to 17 Years Group | Participants aged 12 to 17 years at enrollment. |
| FG002 | Age 18 to 55 Years Group | Participants aged 18 to 55 years at enrollment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age 2 to 11 Years Group | Participants at age 2 to 11 years on enrollment. |
| BG001 | Age 12 to 17 Years Group | Participants aged 12 to 17 years at enrollment. |
| 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 |
| 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 | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test. | Menactra vaccine antibody titers were determined in the immunogenicity analysis set. | Posted | Number | Participants | Baseline and 21 days post-vaccination |
|
Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months 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 | Age 2 to 11 Years Group | Participants at age 2 to 11 years on enrollment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| D016920 | Meningitis, Bacterial |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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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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| Mumbai |
| 400022 |
| India |
| New Delhi | 110002 | India |
| BG002 | Age 18 to 55 Years Group | Participants aged 18 to 55 years at enrollment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG002 |
| Age 18 to 55 Years Group |
Participants aged 18 to 55 years at enrollment |
|
|
| Primary | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Geometric mean titers were determined in the immunogenicity analysis set | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution (1/dil) | Day 0 and Day 30 post-vaccination |
|
|
|
| Primary | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Four-fold antibody increase were determined in the immunogenicity analysis set | Posted | Number | Percentage of Participants | Day 0 to 30 post-vaccination |
|
|
|
| Primary | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia | Safety parameters were assessed in the safety analysis set | Posted | Number | Participants | Day 0 to 7 post-vaccination |
|
|
|
| 0 |
| 100 |
| 30 |
| 100 |
| EG001 | Age 12 to 17 Years Group | Participants aged 12 to 17 years at enrollment. | 0 | 100 | 23 | 100 |
| EG002 | Age 18 to 55 Years Group | Participants aged 18 to 55 years at enrollment | 0 | 100 | 38 | 100 |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 12.0 | 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.
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| Serogroup A (Post-vaccination; N= 99, 97, 98) |
|
| Serogroup C (Pre-vaccination; N= 100, 100, 100) |
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| Serogroup C (Post-vaccination; N= 99, 98, 100) |
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| Serogroup Y (Pre-vaccination; N= 100, 100, 100) |
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| Serogroup Y (Post-vaccination; N= 99, 97, 98) |
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| Serogroup W-135 (Pre-vaccination; N=100, 100, 100) |
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| Serogroup W-135 (Post-vaccination; N= 99, 97, 99) |
|
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| Serogroup Y (N = 99, 97, 98) |
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| Serogroup W-135 (N = 99, 97, 99) |
|
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| Any Solicited injection site erythema |
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| Grade 3 erythema (≥5 cm [2-11 years] or >10 cm) |
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| Any Solicited injection site swelling |
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| Grade 3 swelling (≥5 cm [2-11 years] or >10 cm) |
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| Any Solicited fever |
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| Grade 3 fever (≥ 39.0°C) |
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| Any Solicited headache |
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| Grade 3 headache (significant) |
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| Any Solicited malaise |
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| Grade 3 malaise (significant) |
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| Any Solicited myalgia |
|
| Grade 3 myalgia (significant) |
|