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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: Completed Phase 2 study, sponsored by Sanofi.
NCT00551031 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 2,098 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1477% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
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 |
What the finished NCT00551031 record still lists
NCT00551031 is an interventional study that assigns participants to a tested intervention. Its 2,098 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1477% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00551031's enrollment target sits among peer trials
2,098 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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