Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Public ClinicalTrials.gov record NCT00388583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. 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.
Study identification
- NCT ID
- NCT00388583
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 817 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2006 (Type not available)
- Primary completion
- Jun 2007 (Actual)
- Completion
- Sep 2008 (Actual)
- Last update posted
- Apr 18, 2012
2006 – 2008
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Alabaster | Alabama | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Fountain Valley | California | — | — |
| Not listed | Pinellas Park | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Springfield | Missouri | — | — |
| Not listed | Brooklyn | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Bensalem | Pennsylvania | — | — |
| Not listed | Grove City | Pennsylvania | — | — |
| Not listed | Johnstown | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Galveston | Texas | — | — |
| Not listed | Layton | Utah | — | — |
| Not listed | South Jordan | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00388583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2012 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00388583 live on ClinicalTrials.gov.