Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation

Study Overview
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Brief Summary
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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: To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.

Detailed Description
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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.

Official Title
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Observational Study of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra® Administered in Individuals 2 Through 55 Years Old Under Standard Health Care Practice in the Russian Federation

Conditions
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Meningitis, Meningococcal Meningitis, Meningococcal Infections

Intervention / Treatment
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* Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
* Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
* Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 2 through 55 years on the day of enrollment 2 through 55 years means from the day of the 2nd birthday to the day before the 56th birthday For adults (18-55 years old) Informed consent form has been signed and dated by the participant. For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant: participants aged 14 to 17 years are required to sign and date the informed consent form, participants aged 10 to 13 years are required to sign and date the assent form, for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert. Exclusion Criteria: Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Menactra Study Group 1<br>Participant aged 2 through 11 years at vaccination | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* No vaccine will be provided as part of this study<br>* Other names: Menactra®;|
| Menactra Study Group 2<br>Participant aged 12 through 17 years at vaccination | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* No vaccine will be provided as part of this study<br>* Other names: Menactra®;|
| Menactra Study Group 3<br>Participant aged 18 through 55 years at vaccination | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* No vaccine will be provided as part of this study<br>* Other names: Menactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine