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NCT00262041 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
A Phase 2 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 524
- Enrollment target
NCT00262041: Completed Phase 2 study, sponsored by Novartis Vaccines.
NCT00262041 is a Phase 2 study that has completed, run by Novartis Vaccines. The registered enrollment target is 524 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (294% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262041, a Phase 2 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 524 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
Primary Outcome
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y
Interventions
- BIOLOGICAL MenACWY-CRM conjugate vaccine, adjuvanted
- BIOLOGICAL MenACWY-CRM conjugate vaccine, unadjuvanted
- BIOLOGICAL MenACWY polysaccharide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2004-10 |
| Est. Completion | 2006-03 |
| Phase | Phase 2 |
What the finished NCT00262041 record still lists
NCT00262041 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (294% higher).
The record links to 0 conditions, and to 3 interventions - of which MenACWY-CRM conjugate vaccine, adjuvanted is the first listed.
NCT00262041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00262041 about?
NCT00262041 is a clinical study titled "Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents". The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
What is the current status of trial NCT00262041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 524 participants. The study started on 2004-10. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00262041?
The interventions under investigation include: MenACWY-CRM conjugate vaccine, adjuvanted (BIOLOGICAL), MenACWY-CRM conjugate vaccine, unadjuvanted (BIOLOGICAL), MenACWY polysaccharide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00262041?
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 NCT00262041's enrollment target sits among peer trials
524 65th of 2000 higher than 1,936 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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