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.
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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
- Oct 2006 (Type not available)
- Primary completion
- Jul 2007 (Actual)
- Completion
- Feb 2008 (Actual)
- Last update posted
- Apr 14, 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 14, 2016 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00391053 live on ClinicalTrials.gov.