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

Sanofi

Status

Completed

Conditions

Meningitis

Meningococcal Meningitis

Meningococcal Infections

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT02699840

U1111-1174-4339 (Other Identifier)

MTA92

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

2 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Menactra Study Group 1

Description:

Participant aged 2 through 11 years at vaccination

Treatment:

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

Menactra Study Group 2

Description:

Participant aged 12 through 17 years at vaccination

Treatment:

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

Menactra Study Group 3

Description:

Participant aged 18 through 55 years at vaccination

Treatment:

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

Trial contacts and locations

1

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