Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Completed

Conditions studied: Meningococcal Disease, Infections, Meningococcal

In brief

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.

Key facts

Study ID

NCT02287688

Run by

GlaxoSmithKline

People needed

144

Starts

2014-12-01

Expected to finish

2017-11-29

Last updated by the study team

2019-10-21

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• children 2-23 months of age at the time of MenACWY-CRM vaccination
• hold KPSC membership at the time of MenACWY-CRM vaccination
• vaccinated with MenACWY-CRM during the study period in KPSC

You may not qualify if…

• None

Where it is running

• GSK Investigational Site — Pasadena, California, United States

Full record on ClinicalTrials.gov

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