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COMPLETED Phase 3

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

NCT01641042 · View on ClinicalTrials.gov ↗

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

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01641042

The ClinicalTrials.gov registry entry for NCT01641042 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01641042 reports 16 study locations spanning 3 distinct geographic areas — top geographies include California, North Carolina, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01641042?

The interventions under investigation include: Meningococcal vaccine GSK134612 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01641042?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial