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NCT00614614 · ClinicalTrials.gov registry record · Phase 3

Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

A Phase 3 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,558
Enrollment target
20
Study locations

NCT00614614 is a Phase 3 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,558 participants, above the 301-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (418% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT00614614, a Phase 3 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,558 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Conditions Studied

Infections, Meningococcal

Interventions

  • BIOLOGICAL Pediarix®
  • BIOLOGICAL GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
  • BIOLOGICAL GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
  • BIOLOGICAL Infanrix®
  • BIOLOGICAL ActHIB®

Study Locations (20)

Arkansas

  • GSK Investigational Site - Benton
  • GSK Investigational Site - Fayetteville
  • GSK Investigational Site - Jonesboro
  • GSK Investigational Site - Little Rock

California

  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Fresno
  • GSK Investigational Site - Huntington Beach
  • GSK Investigational Site - West Covina

Alabama

  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Birmingham
  • GSK Investigational Site - Dothan

Florida

  • GSK Investigational Site - Plantation
  • GSK Investigational Site - West Palm Beach

Georgia

  • GSK Investigational Site - Marietta
  • GSK Investigational Site - Woodstock

Iowa

  • GSK Investigational Site - Des Moines
  • GSK Investigational Site - West Des Moines

Idaho

  • GSK Investigational Site - Nampa

Kansas

  • GSK Investigational Site - Arkansas City

Trial Details

FieldValue
Enrollment Target 1,558 participants
Start Date 2008-02-13
Est. Completion 2009-09-17
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00614614

The ClinicalTrials.gov registry entry for NCT00614614 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,558 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 301-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (418% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infections, Meningococcal appearing as the primary indexed condition, and to 5 interventions - of which Pediarix® is the first listed.

NCT00614614 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Arkansas, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00614614 about?

NCT00614614 is a clinical study titled "Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014". The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vacci...

What is the current status of trial NCT00614614?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,558 participants. The study started on 2008-02-13. Estimated completion is 2009-09-17.

What conditions does trial NCT00614614 study?

This clinical trial studies the following conditions: Infections, Meningococcal.

What interventions are being tested in trial NCT00614614?

The interventions under investigation include: Pediarix® (BIOLOGICAL), GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) (BIOLOGICAL), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) (BIOLOGICAL), Infanrix® (BIOLOGICAL), ActHIB® (BIOLOGICAL).

Who is sponsoring clinical trial NCT00614614?

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

Where is trial NCT00614614 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. 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.