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NCT01018732 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
A Phase 2 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
NCT01018732: Completed Phase 2 study, sponsored by Novartis Vaccines.
NCT01018732 is a Phase 2 study that has completed, run by Novartis Vaccines. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01018732, a Phase 2 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). 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
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Interventions
- BIOLOGICAL Novartis Meningococcal (MenACWY-CRM) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT01018732 record still lists
NCT01018732 is an interventional study that assigns participants to a tested intervention. The registered 155 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 (17% higher).
The record links to 0 conditions, and to 1 intervention - of which Novartis Meningococcal (MenACWY-CRM) vaccine is the first listed.
NCT01018732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01018732 about?
NCT01018732 is a clinical study titled "A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY". The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-ma...
What is the current status of trial NCT01018732?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2010-01. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01018732?
The interventions under investigation include: Novartis Meningococcal (MenACWY-CRM) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01018732?
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 NCT01018732's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 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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