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COMPLETED Phase 3

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

NCT00345579 · View on ClinicalTrials.gov ↗

Study Summary

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Interventions

  • BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
  • BIOLOGICAL ActHIB
  • BIOLOGICAL Pediarix/Infanrix Penta

Study Locations (20)

Arkansas

  • GSK Investigational Site — Benton
  • GSK Investigational Site — Fayetteville
  • GSK Investigational Site — Hot Springs
  • GSK Investigational Site — Jonesboro
  • GSK Investigational Site — Little Rock
  • GSK Investigational Site — Little Rock

California

  • GSK Investigational Site — Fountain Valley
  • GSK Investigational Site — Fresno
  • GSK Investigational Site — Fresno
  • GSK Investigational Site — Madera
  • GSK Investigational Site — Slinas
  • GSK Investigational Site — West Covina

Alabama

  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Birmingham

Colorado

  • GSK Investigational Site — Boulder
  • GSK Investigational Site — Longmont

Florida

  • GSK Investigational Site — Plantation

Idaho

  • GSK Investigational Site — Nampa

Illinois

  • GSK Investigational Site — Oak Lawn

Iowa

  • GSK Investigational Site — Waukee

Trial Details

FieldValue
Enrollment Target 4,432 participants
Start Date 2006-09
Est. Completion 2008-03
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00345579

The ClinicalTrials.gov registry entry for NCT00345579 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 4,432 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 2 conditions, with Neisseria Meningitidis appearing as the primary indexed condition, and to 3 interventions — of which GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 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: NCT00345579 reports 20 study locations spanning 8 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 NCT00345579 about?

NCT00345579 is a clinical study titled "Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age". The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome...

What is the current status of trial NCT00345579?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,432 participants. The study started on 2006-09. Estimated completion is 2008-03.

What conditions does trial NCT00345579 study?

This clinical trial studies the following conditions: Neisseria Meningitidis, Haemophilus Influenzae Type b. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00345579?

The interventions under investigation include: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 (BIOLOGICAL), ActHIB (BIOLOGICAL), Pediarix/Infanrix Penta (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00345579?

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 NCT00345579 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. 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