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

Completed

• Conditions: Meningitis; Meningococcal Disease

• Registration Number: NCT00728260
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2015-01-07
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-10
• Last Update Submitted: 2015-02-10
• Results First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1421

Inclusion Criteria

• Receipt of Menactra vaccine during the study period.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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