Clinical trial NCT02287688: Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Disease
Infections, Meningococcal
Keywords: safety of Meningococcal quadrivalent CRM-197 conjugate vaccine
Children 2-23 months of age
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 144
Sex: ALL
Minimum age (years): 2
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.

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.


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

Primary outcomes:
measure: Number of Subjects Who Experienced Single or Multiple Medical Encounters
timeFrame: Within 6 months after any dose of MenACWY-CRM vaccination
measure: Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
timeFrame: Within 6 months after any dose of MenACWY-CRM
measure: Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
timeFrame: Within 6 months after any dose of MenACWY-CRM
measure: Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses
timeFrame: Within 6 months after any dose of MenACWY-CRM
measure: Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
timeFrame: Within 6 months after any dose of MenACWY-CRM
measure: Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
timeFrame: Within 6 months after any dose of MenACWY-CRM
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: