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NCT01974895 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

A Phase 2 study of Influenza, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
316
Enrollment target
12
Study locations

NCT01974895 is a Phase 2 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 316 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 9 states.

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The verdict

NCT01974895, a Phase 2 study of Influenza, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
316 participants
Enrollment target
12
Study locations

Study Summary

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Conditions Studied

Interventions

  • BIOLOGICAL FluLaval® Quadrivalent
  • BIOLOGICAL Fluzone®

Study Locations (12)

California

  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - West Covina

Massachusetts

  • GSK Investigational Site - Fall River
  • GSK Investigational Site - Woburn

South Carolina

  • GSK Investigational Site - Barnwell
  • GSK Investigational Site - Cheraw

Florida

  • GSK Investigational Site - Altamonte Springs

Michigan

  • GSK Investigational Site - Stevensville

New York

  • GSK Investigational Site - Syracuse

Ohio

  • GSK Investigational Site - Cleveland

Pennsylvania

  • GSK Investigational Site - Hermitage

Trial Details

FieldValue
Enrollment Target 316 participants
Start Date 2013-10-23
Est. Completion 2014-07-03
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01974895

The ClinicalTrials.gov registry entry for NCT01974895 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which FluLaval® Quadrivalent is the first listed.

NCT01974895 reports 12 study locations spanning 9 distinct geographic areas - top geographies include California, Massachusetts, South Carolina.

Frequently Asked Questions

What is clinical trial NCT01974895 about?

NCT01974895 is a clinical study titled "Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age". The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

What is the current status of trial NCT01974895?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2013-10-23. Estimated completion is 2014-07-03.

What conditions does trial NCT01974895 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT01974895?

The interventions under investigation include: FluLaval® Quadrivalent (BIOLOGICAL), Fluzone® (BIOLOGICAL).

Who is sponsoring clinical trial NCT01974895?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01974895 being conducted?

This trial has 12 study locations across California, Florida, Massachusetts, Michigan, New York. 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.