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NCT02287688 · ClinicalTrials.gov registry record
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
A clinical trial of Infections, Meningococcal and Meningococcal Disease, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 144
- Enrollment target
- 1
- Study location
NCT02287688: Completed study of Infections, Meningococcal and Meningococcal Disease, sponsored by GlaxoSmithKline.
NCT02287688 is a study of Infections, Meningococcal and Meningococcal Disease that has completed, run by GlaxoSmithKline. The registered enrollment target is 144 participants, below the 503-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287688, a study of Infections, Meningococcal and Meningococcal Disease, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 144 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal quadrivalent CRM-197 conjugate vaccine
Study Locations (1)
California
- GSK Investigational Site - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2014-12-01 |
| Est. Completion | 2017-11-29 |
What the finished NCT02287688 record still lists
NCT02287688 is an observational study that tracks outcomes without assigning an intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 503-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Infections, Meningococcal appearing as the primary indexed condition, and to 1 intervention - of which Meningococcal quadrivalent CRM-197 conjugate vaccine is the first listed.
NCT02287688 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02287688 about?
NCT02287688 is a clinical study titled "Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study". 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 st...
What is the current status of trial NCT02287688?
This trial is currently completed. The enrollment target is 144 participants. The study started on 2014-12-01. Estimated completion is 2017-11-29.
What conditions does trial NCT02287688 study?
This clinical trial studies the following conditions: Infections, Meningococcal, Meningococcal Disease.
What interventions are being tested in trial NCT02287688?
The interventions under investigation include: Meningococcal quadrivalent CRM-197 conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02287688?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287688 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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