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

Completed

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

• 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

Arm && Interventions

Group	Intervention	Description
Menactra Vaccine Recipients	None administered in this study	Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.
Age-Matched Control	None administered in this study	Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente

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.