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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1174-4339 | Other Identifier | WHO |
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The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.
Primary Objective:
Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra Study Group 1 | Participant aged 2 through 11 years at vaccination |
| |
| Menactra Study Group 2 | Participant aged 12 through 17 years at vaccination |
| |
| Menactra Study Group 3 | Participant aged 18 through 55 years at vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Biological | No vaccine will be provided as part of this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine | Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia | Day 0 to Day 7 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine | Day 0 to Day 28 post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 2 to 55 years will be enrolled after receipt of one dose of Menactra® during a routine health care visit.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow | Russia |
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| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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|
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Biological | No vaccine will be provided as part of this study |
|
|
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Biological | No vaccine will be provided as part of this study |
|
|
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
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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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