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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: Completed study of Meningococcal Disease, sponsored by Novartis Vaccines.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01452438 record still lists
NCT01452438 is an observational study that tracks outcomes without assigning an intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, above the 144-participant average among 3 other Meningococcal Disease trials with a reported enrollment target (173% higher).
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 a single indexed study location in 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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