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NCT00831675 · ClinicalTrials.gov registry record · Phase 4

Study of Safety and Immunogenicity of Fluzone® in Healthy Children

A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT00831675 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 30 participants.

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The verdict

NCT00831675, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Interventions

  • BIOLOGICAL Influenza Vaccine 2004-2005 Paediatric Formulation

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-09
Est. Completion 2006-04
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT00831675

The ClinicalTrials.gov registry entry for NCT00831675 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Influenza Vaccine 2004-2005 Paediatric Formulation is the first listed.

NCT00831675 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00831675 about?

NCT00831675 is a clinical study titled "Study of Safety and Immunogenicity of Fluzone® in Healthy Children". To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, ...

What is the current status of trial NCT00831675?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2004-09. Estimated completion is 2006-04.

What interventions are being tested in trial NCT00831675?

The interventions under investigation include: Influenza Vaccine 2004-2005 Paediatric Formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT00831675?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 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.