Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

Completed

• Conditions: Meningitis; Meningococcal Infection

• Registration Number: NCT01689155
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

* To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Detailed Description

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Results First Submitted: 2016-08-01
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-25
• Last Update Submitted: 2016-09-25
• Results First Posted: 2016-11-11
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.	Day 0 up to Day 75 post-vaccination	Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.