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NCT00474526 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

A Phase 3 study of Meningitis, Meningococcal, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 3
Development phase
4,545
Enrollment target
20
Study locations

NCT00474526 is a Phase 3 study of Meningitis, Meningococcal that has completed, run by Novartis Vaccines. The registered enrollment target is 4,545 participants. The trial reports 20 study locations across 7 states.

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The verdict

NCT00474526, a Phase 3 study of Meningitis, Meningococcal, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 3
Development phase
4,545 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Conditions Studied

Interventions

  • BIOLOGICAL Meningococcal ACWY Conjugate Vaccine
  • BIOLOGICAL DTaP-IPV-HBV
  • BIOLOGICAL Hib
  • BIOLOGICAL Rotavirus
  • BIOLOGICAL Pneumococcal 7-valent Conjugate Vaccine

Study Locations (20)

California

  • Premier Health Research Center, LLC - Downey
  • Kaiser Permanente Oakland - Oakland
  • Kaiser Permanente Med Group - Vaccine Study Ctr - Oakland
  • Center for Clinical Trials, LLC - Paramount
  • Kaiser Permanente Pleasanton - Pleasanton
  • Kaiser Permanente Richmond - Richmond
  • Kaiser Permanente San Francisco - San Francisco
  • Kaiser Permanente Santa Clara - Santa Clara
  • UCLA Center for Vaccine Research - Torrence

Alabama

  • Growing Up Pediatrics - Bessemer
  • Alabama Clinical Therapeutics, LLC - Birmingham
  • Growing Up Pediatrics - Birmingham

Maryland

  • Annapolis Pediatrics - Annapolis
  • Center for Vaccine Development - Baltimore
  • The Pediatric Center - Frederick

Colorado

  • The Children's Hospital - Aurora
  • Longmont Medical Research Network - Longmont

Illinois

  • Children's Memorial Hospital - Chicago

Kentucky

  • Kentucky Pediatric/Adult Research Inc. - Bardstown

Massachusetts

  • Boston University Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 4,545 participants
Start Date 2007-03
Est. Completion 2009-11
Phase Phase 3

Sponsor

Novartis Vaccines

32 total trials

What the Registry Record Tells You About NCT00474526

The ClinicalTrials.gov registry entry for NCT00474526 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,545 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 1 condition, with Meningitis, Meningococcal appearing as the primary indexed condition, and to 5 interventions - of which Meningococcal ACWY Conjugate Vaccine is the first listed.

NCT00474526 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Alabama, Maryland.

Frequently Asked Questions

What is clinical trial NCT00474526 about?

NCT00474526 is a clinical study titled "A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants". This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

What is the current status of trial NCT00474526?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,545 participants. The study started on 2007-03. Estimated completion is 2009-11.

What conditions does trial NCT00474526 study?

This clinical trial studies the following conditions: Meningitis, Meningococcal.

What interventions are being tested in trial NCT00474526?

The interventions under investigation include: Meningococcal ACWY Conjugate Vaccine (BIOLOGICAL), DTaP-IPV-HBV (BIOLOGICAL), Hib (BIOLOGICAL), Rotavirus (BIOLOGICAL), Pneumococcal 7-valent Conjugate Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00474526?

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

Where is trial NCT00474526 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Meningitis, Meningococcal

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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.