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NCT01165242 · ClinicalTrials.gov registry record · Phase 2

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

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

Completed
Registry status
Phase 2
Development phase
1,013
Enrollment target
20
Study locations

NCT01165242 is a Phase 2 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,013 participants, above the 379-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT01165242, a Phase 2 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
1,013 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.

Conditions Studied

Infections, Meningococcal

Interventions

  • BIOLOGICAL Meningococcal vaccine GSK 134612
  • BIOLOGICAL Menactra®

Study Locations (20)

California

  • GSK Investigational Site - Paramount
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - Santa Rosa

Georgia

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

Pennsylvania

  • GSK Investigational Site - Carnegie
  • GSK Investigational Site - Erie
  • GSK Investigational Site - Erie

Kentucky

  • GSK Investigational Site - Lexington
  • GSK Investigational Site - Nicholasville

Arizona

  • GSK Investigational Site - Chandler

Colorado

  • GSK Investigational Site - Longmont

Kansas

  • GSK Investigational Site - Wichita

Maryland

  • GSK Investigational Site - Columbia

Trial Details

FieldValue
Enrollment Target 1,013 participants
Start Date 2010-08-19
Est. Completion 2011-07-29
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01165242

The ClinicalTrials.gov registry entry for NCT01165242 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,013 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 379-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (167% 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 2 interventions - of which Meningococcal vaccine GSK 134612 is the first listed.

NCT01165242 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Georgia, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01165242 about?

NCT01165242 is a clinical study titled "Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults". The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.

What is the current status of trial NCT01165242?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,013 participants. The study started on 2010-08-19. Estimated completion is 2011-07-29.

What conditions does trial NCT01165242 study?

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

What interventions are being tested in trial NCT01165242?

The interventions under investigation include: Meningococcal vaccine GSK 134612 (BIOLOGICAL), Menactra® (BIOLOGICAL).

Who is sponsoring clinical trial NCT01165242?

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

Where is trial NCT01165242 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Georgia, Kansas. 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.