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NCT00457249 · ClinicalTrials.gov registry record · Phase 4
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,564
- Enrollment target
NCT00457249 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 1,564 participants.
The verdict
NCT00457249, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,564 participants
- Enrollment target
Study Summary
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.
Interventions
- BIOLOGICAL ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- BIOLOGICAL DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,564 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00457249
The ClinicalTrials.gov registry entry for NCT00457249 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed is the first listed.
NCT00457249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00457249 about?
NCT00457249 is a clinical study titled "A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older". It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11...
What is the current status of trial NCT00457249?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,564 participants. The study started on 2007-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00457249?
The interventions under investigation include: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed (BIOLOGICAL), DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT00457249?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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