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NCT01641042 · ClinicalTrials.gov registry record · Phase 3

Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

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

Completed
Registry status
Phase 3
Development phase
86
Enrollment target
16
Study locations

NCT01641042 is a Phase 3 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 86 participants, below the 512-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (83% lower). The trial reports 16 study locations across 3 states.

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The verdict

NCT01641042, a Phase 3 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
86 participants
Enrollment target
16
Study locations

Study Summary

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.

Conditions Studied

Interventions

  • BIOLOGICAL Meningococcal vaccine GSK134612

Study Locations (16)

California

  • GSK Investigational Site - Antioch
  • GSK Investigational Site - Daly City
  • GSK Investigational Site - Fremont
  • GSK Investigational Site - Hayward
  • GSK Investigational Site - Oakland
  • GSK Investigational Site - Redwood City
  • GSK Investigational Site - Roseville
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - Santa Clara
  • GSK Investigational Site - Santa Rosa
  • GSK Investigational Site - Vallejo

North Carolina

  • GSK Investigational Site - Durham
  • GSK Investigational Site - Durham

Other

  • GSK Investigational Site - Brno
  • GSK Investigational Site - Hradec Králové

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2012-09-10
Est. Completion 2015-03-03
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01641042

The ClinicalTrials.gov registry entry for NCT01641042 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 512-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (83% 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.

NCT01641042 reports 16 study locations spanning 3 distinct geographic areas - top geographies include California, North Carolina, Other.

Frequently Asked Questions

What is clinical trial NCT01641042 about?

NCT01641042 is a clinical study titled "Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects". The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.

What is the current status of trial NCT01641042?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2012-09-10. Estimated completion is 2015-03-03.

What conditions does trial NCT01641042 study?

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

What interventions are being tested in trial NCT01641042?

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

Who is sponsoring clinical trial NCT01641042?

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

Where is trial NCT01641042 being conducted?

This trial has 16 study locations across California, North Carolina. 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.