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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: Completed Phase 3 study of Meningitis, Meningococcal, sponsored by Novartis Vaccines.
NCT00474526 is a Phase 3 study of Meningitis, Meningococcal that has completed, run by Novartis Vaccines. The registered enrollment target is 4,545 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (489% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Immunogenicity as measured by percentage of subjects with hSBA titer \>=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age
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
| Field | Value |
|---|---|
| Enrollment Target | 4,545 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00474526 record still lists
NCT00474526 is an interventional study that assigns participants to a tested intervention. Its 4,545 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (489% higher).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Meningitis, Meningococcal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00474526's enrollment target sits among peer trials
4,545 54th of 2000 higher than 1,947 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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