Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Study Overview
=================
Brief 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.

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.

Conditions
-----------------
Meningococcal Disease, Infections, Meningococcal

Intervention / Treatment
-----------------
* Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 23 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure group<br>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. | Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine<br>* This study is strictly observational. Decisions of vaccination are made by health care providers.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Experienced Single or Multiple Medical Encounters | The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported | Within 6 months after any dose of MenACWY-CRM vaccination | 
| Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination | All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care. | Within 6 months after any dose of MenACWY-CRM | 
| Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination | The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. | Within 6 months after any dose of MenACWY-CRM | 
| Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses | Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported | Within 6 months after any dose of MenACWY-CRM | 
| Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination | All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations. | Within 6 months after any dose of MenACWY-CRM | 
| Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination | The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations. | Within 6 months after any dose of MenACWY-CRM | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety of Meningococcal quadrivalent CRM-197 conjugate vaccine, Children 2-23 months of age