Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

Sanofi

Status: Completed

Conditions: Meningococcal Infection; Meningitis

Treatments: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Study type: Observational

Funder types: Industry

Identifiers

NCT01689155

MTA57

U 1111-1120-1574 (Other Identifier)

Details and patient eligibility

About

This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

• To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Full description

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Enrollment: 116 patients

Sex: All

Ages: 9 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Trial design

116 participants in 1 patient group

Study Group

Description:

Participants must have received Menactra Vaccine according to routine clinical practice.

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate