Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

Sanofi

Status: Completed

Conditions: Meningitis; Meningococcal Disease

Treatments: Biological: None administered in this study

Study type: Observational

Funder types: Industry

Identifiers

NCT00254995

MTA30

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: 62,626 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receipt of Menactra vaccine during the study period.

Exclusion criteria

• None

Trial design

62,626 participants in 2 patient groups

Menactra Vaccine Recipients

Description:

Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.

Treatment:

Biological: None administered in this study

Age-Matched Control

Description:

Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente

Treatment:

Biological: None administered in this study