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NCT00616421 · ClinicalTrials.gov registry record · Phase 3

Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

A Phase 3 study, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 3
Development phase
2,907
Enrollment target

NCT00616421 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 2,907 participants.

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The verdict

NCT00616421, a Phase 3 study, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 3
Development phase
2,907 participants
Enrollment target

Study Summary

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

Interventions

  • BIOLOGICAL MenACWY-CRM
  • BIOLOGICAL Licensed meningococcal ACWY vaccine

Trial Details

FieldValue
Enrollment Target 2,907 participants
Start Date 2008-03
Est. Completion 2009-10
Phase Phase 3

Sponsor

Novartis Vaccines

32 total trials

What the Registry Record Tells You About NCT00616421

The ClinicalTrials.gov registry entry for NCT00616421 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,907 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.

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

NCT00616421 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00616421 about?

NCT00616421 is a clinical study titled "Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children". To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

What is the current status of trial NCT00616421?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,907 participants. The study started on 2008-03. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00616421?

The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), Licensed meningococcal ACWY vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00616421?

This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.

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

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.