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

Completed

• Conditions: Meningitis; Meningococcal Disease
• Interventions: Biological: None administered in this study

• 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

Arm && Interventions

Group	Intervention	Description
Menactra Vaccine Recipients	None administered in this study	Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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. Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses. Menactra vaccine was administered according to routine clinical practice.

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.