Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2017-11-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Disease Infections, Meningococcal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposure group

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.

Meningococcal quadrivalent CRM-197 conjugate vaccine

Intervention Type BIOLOGICAL

This study is strictly observational. Decisions of vaccination are made by health care providers.

Interventions

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