Clinical Trial: Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (MENVEO®) in Children 2 Months Through 23 Months of Age.
Brief Summary:
This safety surveillance study of Novartis quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration.
It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member.
The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Medical events that require emergency room visits or hospitalizations. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded. [ Time Frame: time from the first dose of MenACWY-CRM vaccination up to 6 months after the last dose of MenACWY-CRM vaccination received between 2-23 months of age, disenrollment, death, or the end of data collection, whichever occurs sooner. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: October 27, 2014
Date Started: December 1, 2014
Date Completion: November 30, 2017
Last Updated: May 17, 2017
Last Verified: May 2017
