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NCT00856297 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 389
- Enrollment target
NCT00856297: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT00856297 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 389 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00856297, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 389 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Primary Outcome
Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.
Interventions
- BIOLOGICAL MenACWY-CRM conjugate vaccine
- BIOLOGICAL Licensed comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT00856297 record still lists
NCT00856297 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which MenACWY-CRM conjugate vaccine is the first listed.
NCT00856297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00856297 about?
NCT00856297 is a clinical study titled "Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine". The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have ...
What is the current status of trial NCT00856297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 389 participants. The study started on 2009-02. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00856297?
The interventions under investigation include: MenACWY-CRM conjugate vaccine (BIOLOGICAL), Licensed comparator (BIOLOGICAL).
Who is sponsoring clinical trial NCT00856297?
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 NCT00856297's enrollment target sits among peer trials
389 972nd of 2000 higher than 1,028 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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