Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Meningococcal; Meningococcal Disease

Treatments: Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT02287688

V59_74OB (Other Identifier)

205534

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 2 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• None

Trial design

144 participants in 1 patient group

Exposure group

Description:

Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.

Treatment:

Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine