NCT02287688

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (MENVEO®) in Children 2 Months Through 23 Months of Age.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

This safety surveillance study of GlaxoSmithKline's 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.

Conditions

• Meningococcal Disease
• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal quadrivalent CRM-197 conjugate vaccine	This study is strictly observational. Decisions of vaccination are made by health care providers.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-11-29
• Completion: 2017-11-29
• First posted: 2014-11-11
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

1 site across 1 country: United States