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NCT00254995 · ClinicalTrials.gov registry record
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
A clinical trial, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 62,626
- Enrollment target
NCT00254995: Completed study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00254995 is a clinical trial that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 62,626 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254995 has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 62,626 participants
- Enrollment target
Study Summary
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
Primary Outcome
Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for
Interventions
- BIOLOGICAL None administered in this study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62,626 participants |
| Start Date | 2005-07 |
| Est. Completion | 2013-05 |
What the finished NCT00254995 record still lists
NCT00254995 is an observational study that tracks outcomes without assigning an intervention. Its 62,626 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which None administered in this study is the first listed.
NCT00254995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00254995 about?
NCT00254995 is a clinical study titled "Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine". To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
What is the current status of trial NCT00254995?
This trial is currently completed. The enrollment target is 62,626 participants. The study started on 2005-07. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00254995?
The interventions under investigation include: None administered in this study (BIOLOGICAL).
Who is sponsoring clinical trial NCT00254995?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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