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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-4853 | Other Identifier | WHO |
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This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® Group 1 | Experimental | Participants aged 2 to 11 on enrollment |
|
| Menactra® Group 2 | Experimental | Participants aged 12 to 17 on enrollment |
|
| Menactra® Group 3 | Experimental | Participants aged 18 to 55 on enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Overview Within 30 Days in Participants Vaccinated With Menactra® | Day 0 up to Day 30 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® | Day 0 up to Day 30 post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Philippines, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Santos | Antique | Philippines | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 538 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
The study participants were enrolled from 16 December 2010 through 15 November 2012 at 130 clinic centers in thePhillipines
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Vaccine Group | Participants who received a single dose of Menactra vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
|
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, Intramuscular |
|
|
| Calamba |
| Bataan |
| Philippines |
| Marikina City | Batangas | Philippines |
| Montalban | Batangas | Philippines |
| Navotas | Batangas | Philippines |
| Noveleta | Batangas | Philippines |
| Olongapo City | Batangas | Philippines |
| Paranaque City | Batangas | Philippines |
| Pasay | Batangas | Philippines |
| Pasig | Batangas | Philippines |
| Plaridel | Batangas | Philippines |
| Quezon City | Batangas | Philippines |
| Angeles City | Benguet | Philippines |
| Bacolod City | Benguet | Philippines |
| Baguio City | Benguet | Philippines |
| Baliwag | Benguet | Philippines |
| Cagayan de Oro | Bulacan | Philippines |
| Cardona | Bulacan | Philippines |
| Cavite City | Bulacan | Philippines |
| Cebu | Bulacan | Philippines |
| Cebu | Capiz | Philippines |
| City of Muntinlupa | Cavite | Philippines |
| Naguila | Cavite | Philippines |
| Olongapo City | Cavite | Philippines |
| Ormoc City | Cavite | Philippines |
| Ortigas | Cavite | Philippines |
| Paranaque City | Cavite | Philippines |
| Pasay | Cavite | Philippines |
| Pasig | Cavite | Philippines |
| Pulilan | Cavite | Philippines |
| Quezon City | Cavite | Philippines |
| Quezon City | Cebu | Philippines |
| Roxas | Cebu | Philippines |
| San Fernando City | Cebu | Philippines |
| San Jose | Cebu | Philippines |
| Santa Rosa | Cebu | Philippines |
| Tagug | Davao Del Norte | Philippines |
| City of Taguig | Davao Del Sur | Philippines |
| Santa Rosa | Davao Del Sur | Philippines |
| Tacloban City | Davao Del Sur | Philippines |
| Talisay City | Davao Del Sur | Philippines |
| Tarlac City | Davao Del Sur | Philippines |
| Taytay | Davao Del Sur | Philippines |
| Theresa | Davao Del Sur | Philippines |
| Valenzuela | Davao Del Sur | Philippines |
| Bacolod City | Ilocos Norte | Philippines |
| Baguio City | Ilocos Norte | Philippines |
| Dasmariñas | Iloilo | Philippines |
| General Santos | Iloilo | Philippines |
| Iloilo City | Iloilo | Philippines |
| Angeles City | Isabela | Philippines |
| Baguio City | Isabela | Philippines |
| Alaminos | LA Union | Philippines |
| Bacolod City | La Union | Philippines |
| City of Muntinlupa | Laguna | Philippines |
| Ormoc City | Laguna | Philippines |
| Quezon City | Laguna | Philippines |
| Tacloban City | Lanao Del Norte | Philippines |
| Tanauan | Lanao Del Norte | Philippines |
| Quezon City | Leyte | Philippines |
| San Fernando City | Leyte | Philippines |
| San Miguel | Leyte | Philippines |
| City of Taguig | Misamis Oriental | Philippines |
| Santa Rosa | Misamis Oriental | Philippines |
| Tarlac City | Misamis Oriental | Philippines |
| Batangas | NCR | Philippines |
| Bocaue | NCR | Philippines |
| Cabanatuan City | NCR | Philippines |
| Calamba | NCR | Philippines |
| Caloocan | NCR | Philippines |
| Cebu | NCR | Philippines |
| Concepcion | NCR | Philippines |
| Dagupan | NCR | Philippines |
| Dasmariñas | NCR | Philippines |
| Davao City | NCR | Philippines |
| Fairview | NCR | Philippines |
| Guagua | NCR | Philippines |
| Iligan City | NCR | Philippines |
| Iloilo City | NCR | Philippines |
| Imus | NCR | Philippines |
| Kidapawan | NCR | Philippines |
| La Trinidad | NCR | Philippines |
| Laoag | NCR | Philippines |
| Las Piñas | NCR | Philippines |
| Lipa | NCR | Philippines |
| Lipa City | NCR | Philippines |
| Los Baños | NCR | Philippines |
| Maasin | NCR | Philippines |
| Makati | NCR | Philippines |
| Makati City | NCR | Philippines |
| Malabon | NCR | Philippines |
| Malolos | NCR | Philippines |
| Mandaluyong | NCR | Philippines |
| Quezon City | Negros Occidental | Philippines |
| Roxas City | Negros Occidental | Philippines |
| San Fernando City | Negros Occidental | Philippines |
| San Jose del Monte | Negros Occidental | Philippines |
| Urdaneta | North Cotobato | Philippines |
| Manila | NRC | Philippines |
| Marikina City | NRC | Philippines |
| Baguio City | Nueva Ecija | Philippines |
| Batangas | Pampanga | Philippines |
| Biñan | Pampanga | Philippines |
| Cagayan de Oro | Pampanga | Philippines |
| Caloocan | Pampanga | Philippines |
| Cebu | Pampanga | Philippines |
| Angeles City | Pangasinan | Philippines |
| Bacoor | Pangasinan | Philippines |
| Baguio City | Pangasinan | Philippines |
| Balanga | Pangasinan | Philippines |
| Imus | Pasig City | Philippines |
| Concepcion | Rizal | Philippines |
| Davao City | Rizal | Philippines |
| General Santos | Rizal | Philippines |
| Imus | Rizal | Philippines |
| Tacloban City | South Cotabato | Philippines |
| Tagum | South Cotabato | Philippines |
| Tanauan | South Cotabato | Philippines |
| Tarlac City | South Cotabato | Philippines |
| Taytay | South Cotabato | Philippines |
| San Pedro | Southern Leyte | Philippines |
| Angeles City | Tarlac | Philippines |
| Bacolod City | Tarlac | Philippines |
| Baguio City | Tarlac | Philippines |
| Batangas | Zambales | Philippines |
| Calamba | Zambales | Philippines |
| Cauayan | Zambales | Philippines |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Vaccine Group | Participants who received a single dose of Menactra vaccine |
| 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 |
| ||||||||||||||||||||||
| Gender | Gender information was missing for 3 participants in the study | Number | 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 | Safety Overview Within 30 Days in Participants Vaccinated With Menactra® | Post-vaccination safety were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 30 post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra® | Post-vaccination safety were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 30 post-vaccination |
|
|
Adverse event data were collected from Day 0 (post vaccination) up to Day 30 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® Vaccine Group | Participants who received a single dose of Menactra vaccine | 0 | 538 | 0 | 537 |
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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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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Pyrexia |
| |||||
| Other non-serious related adverse events |
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