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COMPLETED Phase 3

Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

NCT00224471 · View on ClinicalTrials.gov ↗

Study Summary

Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.

Conditions Studied

Interventions

  • BIOLOGICAL GSK208141 vaccine

Study Locations (13)

Utah

  • GSK Investigational Site — Salt Lake City
  • GSK Investigational Site — Salt Lake City

Arizona

  • GSK Investigational Site — Mesa

California

  • GSK Investigational Site — Fountain Valley

Colorado

  • GSK Investigational Site — Golden

Ohio

  • GSK Investigational Site — Cincinnati

South Carolina

  • GSK Investigational Site — Charleston

Texas

  • GSK Investigational Site — Galveston

Washington

  • GSK Investigational Site — Seattle

Trial Details

FieldValue
Enrollment Target 671 participants
Start Date 2003-12
Est. Completion 2006-01
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00224471

The ClinicalTrials.gov registry entry for NCT00224471 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 671 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 Herpes Simplex appearing as the primary indexed condition, and to 1 intervention — of which GSK208141 vaccine 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: NCT00224471 reports 13 study locations spanning 12 distinct geographic areas — top geographies include Utah, Arizona, California. 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 NCT00224471 about?

NCT00224471 is a clinical study titled "Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine". Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesize...

What is the current status of trial NCT00224471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2003-12. Estimated completion is 2006-01.

What conditions does trial NCT00224471 study?

This clinical trial studies the following conditions: Herpes Simplex. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00224471?

The interventions under investigation include: GSK208141 vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00224471?

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 NCT00224471 being conducted?

This trial has 13 study locations across Arizona, California, Colorado, Ohio, South 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