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

Sanofi Pasteur, a Sanofi Company1,421 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

1,421

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 Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.

Time frame: Day 0 up to Day 30 post-vaccination

Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

Time frame: Day 31 up to Day 180 post-vaccination

Data from ClinicalTrials.gov

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