Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
Public ClinicalTrials.gov record NCT00391053. 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
Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00391053
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,851 participants
Conditions and interventions
Interventions
- High-Dose Inactivated, Split-Virion Influenza Vaccine Biological
- Inactivated, Split-Virion Influenza Vaccine Biological
Biological
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 30, 2006
- Primary completion
- Jun 30, 2007
- Completion
- Jan 31, 2008
- Last update posted
- Apr 13, 2016
2006 – 2008
United States locations
- U.S. sites
- 28
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mesa | Arizona | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tempe | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Stratford | Connecticut | — | — |
| Not listed | Clearwater | Florida | — | — |
| Not listed | Coral Gables | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Pembroke Pines | Florida | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | Rockville | Maryland | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Endwell | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Cary | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Downington | Pennsylvania | — | — |
| Not listed | Erie | Pennsylvania | — | — |
| Not listed | Warwick | Rhode Island | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Plano | Texas | — | — |
| Not listed | West Jordan | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
| 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 NCT00391053, 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 13, 2016 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00391053 live on ClinicalTrials.gov.