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

Sanofi Pasteur, a Sanofi Company0 sites100 target enrollmentFebruary 2016

ConditionsMeningitis Meningococcal Meningitis Meningococcal Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meningitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 100
Primary Endpoint: Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

July 25, 2016

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine

Time Frame: Day 0 to Day 7 post-vaccination

Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia

Secondary Outcomes

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)