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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 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 433 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01148017
The ClinicalTrials.gov registry entry for NCT01148017 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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