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NCT01823536 · ClinicalTrials.gov registry record · Phase 4
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
A Phase 4 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 4
- Development phase
- 465
- Enrollment target
NCT01823536: Completed Phase 4 study, sponsored by Novartis Vaccines.
NCT01823536 is a Phase 4 study that has completed, run by Novartis Vaccines. The registered enrollment target is 465 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01823536, a Phase 4 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 465 participants
- Enrollment target
Study Summary
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
Primary Outcome
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).
Interventions
- BIOLOGICAL Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01823536 record still lists
NCT01823536 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% 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.
NCT01823536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01823536 about?
NCT01823536 is a clinical study titled "Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose". In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent st...
What is the current status of trial NCT01823536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 465 participants. The study started on 2013-05. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01823536?
The interventions under investigation include: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01823536?
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 NCT01823536's enrollment target sits among peer trials
465 182nd of 2000 higher than 1,818 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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