Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00391053 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,851
- Enrollment target
NCT00391053 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,851 participants.
The verdict
NCT00391053, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,851 participants
- Enrollment target
Study Summary
Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: Immunogenicity: * To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots. * To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine. Secondary Objectives: Immunogenicity: * To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine. Safety: * To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination. * To describe clinical information on some additional defined criteria during the six months following vaccination.
Interventions
- BIOLOGICAL High-Dose Inactivated, Split-Virion Influenza Vaccine
- BIOLOGICAL Inactivated, Split-Virion Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,851 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00391053
The ClinicalTrials.gov registry entry for NCT00391053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,851 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which High-Dose Inactivated, Split-Virion Influenza Vaccine is the first listed.
NCT00391053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00391053 about?
NCT00391053 is a clinical study titled "Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly". Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: ...
What is the current status of trial NCT00391053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,851 participants. The study started on 2006-10. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00391053?
The interventions under investigation include: High-Dose Inactivated, Split-Virion Influenza Vaccine (BIOLOGICAL), Inactivated, Split-Virion Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00391053?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.