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

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections

Interventions: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 55 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Moscow, Russia