36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

Sanofi

Status: Completed

Conditions: Meningitis; Meningococcal Disease

Treatments: Biological: None administered in this study

Study type: Observational

Funder types: Industry

Identifiers

NCT00728260

MTA38

Details and patient eligibility

About

To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Enrollment: 1,421 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receipt of Menactra vaccine during the study period.

Exclusion criteria

• None

Trial design

1,421 participants in 1 patient group

Menactra Vaccine Recipients

Description:

Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses. Menactra vaccine was administered according to routine clinical practice.

Treatment:

Biological: None administered in this study