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

Sanofi Pasteur, a Sanofi Company62,626 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

62,626

Conditions

Meningitis Meningococcal Disease

Interventions

None administered in this studyBIOLOGICAL

N/A in this study

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Receipt of Menactra vaccine during the study period. Exclusion Criteria: * None

Locations (1)

Unnamed facility

Oakland, California, United States

Outcomes

Primary Outcomes

Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance

Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine 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. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

Time frame: Day 0 up to Day 60 post-vaccination

Data from ClinicalTrials.gov

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