Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.

Sanofi Pasteur, a Sanofi Company0 sites1,421 target enrollmentJuly 2005

ConditionsMeningitis Meningococcal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meningitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 1421
Primary Endpoint: Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

May 2013

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Receipt of Menactra vaccine during the study period.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

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.