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NCT00450437 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,539
- Enrollment target
NCT00450437: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT00450437 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 3,539 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (358% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450437, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,539 participants
- Enrollment target
Study Summary
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
Primary Outcome
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Interventions
- BIOLOGICAL MenACWY CRM
- BIOLOGICAL Meningococcal ACWY Conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,539 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00450437 record still lists
NCT00450437 is an interventional study that assigns participants to a tested intervention. Its 3,539 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 (358% higher).
The record links to 0 conditions, and to 2 interventions - of which MenACWY CRM is the first listed.
NCT00450437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00450437 about?
NCT00450437 is a clinical study titled "A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults". This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
What is the current status of trial NCT00450437?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,539 participants. The study started on 2007-03. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00450437?
The interventions under investigation include: MenACWY CRM (BIOLOGICAL), Meningococcal ACWY Conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00450437?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00450437's enrollment target sits among peer trials
3,539 68th of 2000 higher than 1,933 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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