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NCT00718666 · ClinicalTrials.gov registry record · Phase 2

The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers

A Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
387
Enrollment target
14
Study locations

NCT00718666 is a Phase 2 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 387 participants, below the 469-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (17% lower). The trial reports 14 study locations across 5 states.

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The verdict

NCT00718666, a Phase 2 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
387 participants
Enrollment target
14
Study locations

Study Summary

In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.

Conditions Studied

Interventions

  • BIOLOGICAL Meningococcal vaccine GSK134612

Study Locations (14)

California

  • GSK Investigational Site - Antioch
  • GSK Investigational Site - Fremont
  • GSK Investigational Site - Hayward
  • GSK Investigational Site - Santa Rosa
  • GSK Investigational Site - Vacaville

Colorado

  • GSK Investigational Site - Lakewood
  • GSK Investigational Site - Littleton
  • GSK Investigational Site - Littleton
  • GSK Investigational Site - Westminster
  • GSK Investigational Site - Wheat Ridge

Arkansas

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

Ohio

  • GSK Investigational Site - Canton

Texas

  • GSK Investigational Site - Amarillo

Trial Details

FieldValue
Enrollment Target 387 participants
Start Date 2008-10-20
Est. Completion 2014-03-28
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00718666

The ClinicalTrials.gov registry entry for NCT00718666 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 387 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 469-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (17% lower). 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 1 intervention - of which Meningococcal vaccine GSK134612 is the first listed.

NCT00718666 reports 14 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00718666 about?

NCT00718666 is a clinical study titled "The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers". In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting wi...

What is the current status of trial NCT00718666?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 387 participants. The study started on 2008-10-20. Estimated completion is 2014-03-28.

What conditions does trial NCT00718666 study?

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

What interventions are being tested in trial NCT00718666?

The interventions under investigation include: Meningococcal vaccine GSK134612 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00718666?

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

Where is trial NCT00718666 being conducted?

This trial has 14 study locations across Arkansas, California, Colorado, Ohio, Texas. 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.