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NCT00804284 · ClinicalTrials.gov registry record
Database Surveillance Safety Study of PENTACEL® Vaccine
A clinical trial, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 62,538
- Enrollment target
NCT00804284: Completed study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00804284 is a clinical trial that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 62,538 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00804284 has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 62,538 participants
- Enrollment target
Study Summary
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
Primary Outcome
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: * Death, * Outpatient clinic visit for: * seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis * hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxi
Interventions
- BIOLOGICAL DTaP-IPV/Hib
- BIOLOGICAL Other DTap Vaccines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62,538 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-01 |
What the finished NCT00804284 record still lists
NCT00804284 is an observational study that tracks outcomes without assigning an intervention. Its 62,538 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which DTaP-IPV/Hib is the first listed.
NCT00804284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00804284 about?
NCT00804284 is a clinical study titled "Database Surveillance Safety Study of PENTACEL® Vaccine". The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
What is the current status of trial NCT00804284?
This trial is currently completed. The enrollment target is 62,538 participants. The study started on 2008-09. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00804284?
The interventions under investigation include: DTaP-IPV/Hib (BIOLOGICAL), Other DTap Vaccines (BIOLOGICAL).
Who is sponsoring clinical trial NCT00804284?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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