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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 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.

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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.

Interventions

  • BIOLOGICAL Meningococcal quadrivalent CRM-197 conjugate vaccine

Study Locations (1)

California

  • GSK Investigational Site - Pasadena

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2014-12-01
Est. Completion 2017-11-29

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT02287688

The ClinicalTrials.gov registry entry for NCT02287688 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 503-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (71% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.