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NCT00551031 · ClinicalTrials.gov registry record · Phase 2
Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,098
- Enrollment target
NCT00551031 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 2,098 participants.
The verdict
NCT00551031, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,098 participants
- Enrollment target
Study Summary
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Interventions
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,098 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00551031
The ClinicalTrials.gov registry entry for NCT00551031 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,098 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 4 interventions - of which Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1) is the first listed.
NCT00551031 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00551031 about?
NCT00551031 is a clinical study titled "Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects". The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of ...
What is the current status of trial NCT00551031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,098 participants. The study started on 2007-10. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00551031?
The interventions under investigation include: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1) (BIOLOGICAL), Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2) (BIOLOGICAL), Split, Inactivated, Trivalent Influenza Vaccine (Standard dose) (BIOLOGICAL), Split, Inactivated, Trivalent Influenza Vaccine (High-dose) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00551031?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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