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

Completed

• Conditions: Meningococcal Disease; Meningitis

• Registration Number: NCT00254995
• 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: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-09-04
• Results First Submitted QC: 2014-11-03
• Results First Posted: 2014-11-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62626

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 Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance	Day 0 up to Day 60 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 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.