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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 is a Phase 4 study that has completed, run by Novartis Vaccines. The registered enrollment target is 465 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01823536
The ClinicalTrials.gov registry entry for NCT01823536 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 465 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.
NCT01823536 reports 0 study locations.
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.
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