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NCT00383123 · ClinicalTrials.gov registry record · Phase 3

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
3,327
Enrollment target

NCT00383123 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,327 participants.

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The verdict

NCT00383123, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
3,327 participants
Enrollment target

Study Summary

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Interventions

  • BIOLOGICAL Fluzone
  • BIOLOGICAL Fluarix™

Trial Details

FieldValue
Enrollment Target 3,327 participants
Start Date 2006-11-02
Est. Completion 2007-10-19
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00383123

The ClinicalTrials.gov registry entry for NCT00383123 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Fluzone is the first listed.

NCT00383123 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00383123 about?

NCT00383123 is a clinical study titled "Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children". The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

What is the current status of trial NCT00383123?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,327 participants. The study started on 2006-11-02. Estimated completion is 2007-10-19.

What interventions are being tested in trial NCT00383123?

The interventions under investigation include: Fluzone (BIOLOGICAL), Fluarix™ (BIOLOGICAL).

Who is sponsoring clinical trial NCT00383123?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.