NCT02699840

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	No vaccine will be provided as part of this study
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	No vaccine will be provided as part of this study
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	No vaccine will be provided as part of this study

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-25
• Completion: 2016-07-25
• First posted: 2016-03-04
• Last updated: 2022-04-25

Locations

1 site across 1 country: Russia