Clinical trialNCT00566345CompletedPhase 3Interventional

Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

SponsorAlachua Government Services, Inc.Enrollment3,670Influenza

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Karen Near, MD
Baxter Healthcare Corporation
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

34 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Facility name not stated
Tucson, Arizona, United States
Facility name not stated
Anaheim, California, United States
Facility name not stated
Sacramento, California, United States
Facility name not stated
San Diego, California, United States
Facility name not stated
San Francisco, California, United States
Facility name not stated
Clearwater, Florida, United States
Facility name not stated
Jacksonville, Florida, United States
Facility name not stated
Pembroke Pines, Florida, United States
Facility name not stated
South Miami, Florida, United States
Facility name not stated
Chicago, Illinois, United States
Facility name not stated
Lenexa, Kansas, United States
Facility name not stated
Overland Park, Kansas, United States
Facility name not stated
Lexington, Kentucky, United States
Facility name not stated
Metairie, Louisiana, United States
Facility name not stated
Columbia, Maryland, United States
Facility name not stated
Kansas City, Missouri, United States
Facility name not stated
St Louis, Missouri, United States
Facility name not stated
Omaha, Nebraska, United States
Facility name not stated
Las Vegas, Nevada, United States
Facility name not stated
Rochester, New York, United States
Facility name not stated
Charlotte, North Carolina, United States
Facility name not stated
Raleigh, North Carolina, United States
Facility name not stated
Winston-Salem, North Carolina, United States
Facility name not stated
Goose Creek, South Carolina, United States
Facility name not stated
Spartanburg, South Carolina, United States
Facility name not stated
Nashville, Tennessee, United States
Facility name not stated
Austin, Texas, United States
Facility name not stated
Dallas, Texas, United States
Facility name not stated
Fort Worth, Texas, United States
Facility name not stated
Plano, Texas, United States
Facility name not stated
San Angelo, Texas, United States
Facility name not stated
San Antonio, Texas, United States
Facility name not stated
Salt Lake City, Utah, United States
Facility name not stated
Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Inactivated seasonal influenza vaccine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2007
Primary completion: 30 Jun 2008
Completion: 30 Jun 2008
Last update posted: 17 Oct 2023
Registered enrollment: 3,670
Registry id: NCT00566345

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.