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COMPLETED Phase 3

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

NCT00614614 · View on ClinicalTrials.gov ↗

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

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

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00614614

The ClinicalTrials.gov registry entry for NCT00614614 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 1,558 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 5 interventions — of which Pediarix® 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: NCT00614614 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Arkansas, California, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00614614?

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 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.

Related

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