Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
Public ClinicalTrials.gov record NCT00551031. 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 Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00551031
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,098 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 18 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 30, 2007
- Primary completion
- May 31, 2008
- Completion
- Oct 31, 2008
- Last update posted
- May 15, 2016
2007 – 2008
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Alabaster | Alabama | — | — |
| Not listed | Mobile | Alabama | — | — |
| Not listed | Chandler | Arizona | — | — |
| Not listed | Mesa | Arizona | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Fountain Valley | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Stanford | Connecticut | — | — |
| Not listed | Pembroke Pines | Florida | — | — |
| Not listed | Pinellas Park | Florida | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Springfield | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Cary | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Allentown | Pennsylvania | — | — |
| Not listed | Bensalem | Pennsylvania | — | — |
| Not listed | Warwick | Rhode Island | — | — |
| Not listed | Goose Creek | South Carolina | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Galveston | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | West Jordan | Utah | — | — |
| Not listed | Marshfield | Wisconsin | — | — |
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 NCT00551031, 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 May 15, 2016 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00551031 live on ClinicalTrials.gov.