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NCT01452464 · ClinicalTrials.gov registry record
Safety of MenACWY-CRM Vaccination in Adolescents
A clinical trial, sponsored by Novartis Vaccines.
- Completed
- Registry status
- 55,397
- Enrollment target
NCT01452464 is a clinical trial that has completed, run by Novartis Vaccines. The registered enrollment target is 55,397 participants.
The verdict
NCT01452464 has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- 55,397 participants
- Enrollment target
Study Summary
The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.
Interventions
- BIOLOGICAL MenACWY-CRM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55,397 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-02 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452464
The ClinicalTrials.gov registry entry for NCT01452464 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 55,397 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 MenACWY-CRM is the first listed.
NCT01452464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01452464 about?
NCT01452464 is a clinical study titled "Safety of MenACWY-CRM Vaccination in Adolescents". The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of in...
What is the current status of trial NCT01452464?
This trial is currently completed. The enrollment target is 55,397 participants. The study started on 2011-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01452464?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL).
Who is sponsoring clinical trial NCT01452464?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
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