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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: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00391053 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,851 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (399% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
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 |
What the finished NCT00391053 record still lists
NCT00391053 is an interventional study that assigns participants to a tested intervention. Its 3,851 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (399% higher).
The record links to 0 conditions, and to 2 interventions - of which High-Dose Inactivated, Split-Virion Influenza Vaccine is the first listed.
NCT00391053 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00391053's enrollment target sits among peer trials
3,851 66th of 2000 higher than 1,935 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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