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NCT00643916 · ClinicalTrials.gov registry record · Phase 2

Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
378
Enrollment target

NCT00643916 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 378 participants.

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The verdict

NCT00643916, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
378 participants
Enrollment target

Study Summary

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Interventions

  • BIOLOGICAL Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)

Trial Details

FieldValue
Enrollment Target 378 participants
Start Date 2004-12
Est. Completion 2007-10
Phase Phase 2

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT00643916

The ClinicalTrials.gov registry entry for NCT00643916 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 378 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 Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) is the first listed.

NCT00643916 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00643916 about?

NCT00643916 is a clinical study titled "Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age". The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered t...

What is the current status of trial NCT00643916?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 378 participants. The study started on 2004-12. Estimated completion is 2007-10.

What interventions are being tested in trial NCT00643916?

The interventions under investigation include: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00643916?

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.