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NCT01148017 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
NCT01148017: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT01148017 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 433 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01148017, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.
Primary Outcome
The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Interventions
- BIOLOGICAL Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01148017 record still lists
NCT01148017 is an interventional study that assigns participants to a tested intervention. The registered 433 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 (44% lower).
The record links to 0 conditions, and to 1 intervention - of which Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine is the first listed.
NCT01148017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01148017 about?
NCT01148017 is a clinical study titled "Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine". The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningo...
What is the current status of trial NCT01148017?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2010-07. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01148017?
The interventions under investigation include: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01148017?
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 NCT01148017's enrollment target sits among peer trials
433 876th of 2000 higher than 1,125 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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