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NCT01452438 · ClinicalTrials.gov registry record
Safety Surveillance of MenACWY-CRM Vaccine in Children
A clinical trial of Meningococcal Disease, sponsored by Novartis Vaccines.
- Completed
- Registry status
- 393
- Enrollment target
- 1
- Study location
NCT01452438 is a study of Meningococcal Disease that has completed, run by Novartis Vaccines. The registered enrollment target is 393 participants, above the 144-participant average among 3 other Meningococcal Disease trials with a reported enrollment target (173% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01452438, a study of Meningococcal Disease, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- 393 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 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.
Conditions Studied
Interventions
- BIOLOGICAL MenACWY-CRM
Study Locations (1)
California
- Kaiser Permanente South California - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452438
The ClinicalTrials.gov registry entry for NCT01452438 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 393 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 144-participant average among 3 other Meningococcal Disease trials with a reported enrollment target (173% higher). The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Meningococcal Disease appearing as the primary indexed condition, and to 1 intervention - of which MenACWY-CRM is the first listed.
NCT01452438 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01452438 about?
NCT01452438 is a clinical study titled "Safety Surveillance of MenACWY-CRM Vaccine in Children". The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epide...
What is the current status of trial NCT01452438?
This trial is currently completed. The enrollment target is 393 participants. The study started on 2011-09. Estimated completion is 2015-07.
What conditions does trial NCT01452438 study?
This clinical trial studies the following conditions: Meningococcal Disease.
What interventions are being tested in trial NCT01452438?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL).
Who is sponsoring clinical trial NCT01452438?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01452438 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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