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The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.
Primary objective:
To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Vaccine Group | Experimental | Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine |
|
| Hiberix® Vaccine Group | Active Comparator | Participants receiving Haemophilus Influenzae Type b (Hib) vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. | Day 0 (before) and 28 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. | 28 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 |
|---|---|---|---|---|---|---|
| London | E1 1BB | United Kingdom | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16417952 | Result | El Bashir H, Heath PT, Papa T, Ruggeberg JU, Johnson N, Sinha R, Balfour G, Booy R. Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine. Vaccine. 2006 Mar 24;24(14):2544-9. doi: 10.1016/j.vaccine.2005.12.018. Epub 2005 Dec 27. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 103 subjects that met the inclusion but none of the exclusion criteria were enrolled, 102 subjects were vaccinated.
Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Vaccine Group | Participants received Menactra® Vaccine |
| FG001 | Hiberix® Vaccine Group | Participants received Hiberix® Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Haemophilus Influenzae Type b (Hib) vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| London |
| SW17 ORE |
| United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Vaccine Group | Participants received Menactra® Vaccine |
| BG001 | Hiberix® Vaccine Group | Participants received Hiberix® 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||||
| 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 | Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. | SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (before) and 28 days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. | SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population. | Posted | Number | Participants | 28 days post-vaccination |
|
|
Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
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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 | Participants received Menactra® Vaccine | 1 | 52 | 15 | 52 | ||
| EG001 | Hiberix® Vaccine Group | Participants received Hiberix® Vaccine | 0 | 50 | 22 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pyrexia | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Otitis media NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | 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 |
| D014612 | Vaccines |
| C514867 | Hiberix |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
|
| Male |
|
| Meningococcal Serogroup C - Day 0 |
|
| Meningococcal Serogroup C - Day 28 |
|
| Meningococcal Serogroup Y - Day 0 |
|
| Meningococcal Serogroup Y - Day 28 |
|
| Meningococcal Serogroup W-135 - Day 0 |
|
| Meningococcal Serogroup W-135 - Day 28 |
|
|