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New Cell-Based flu shot shows promise for older adults

NCT ID NCT00782431

Vaccine Sponsor: Alachua Government Services, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new seasonal flu vaccine made from animal cells instead of eggs in over 3,200 adults aged 50 and older. Participants received either the new vaccine or a standard egg-based flu shot, and researchers measured their immune response and side effects. The goal was to see if the cell-based vaccine works as well as the standard vaccine in protecting against the flu.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,208 people

The number who actually took part.

Start date

Nov 2008

Finished

Jul 2009

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Are 50 years of age or older on the day of screening * Have an understanding of the study, agree to its provisions, have the ability to adhere to the provisions of the study and give written informed consent prior to study entry * If female and capable of bearing children,have a negative urine pregnancy test result within 24 hours prior to the vaccination on Study Day 0 and agree to employ adequate birth control measures. Exclusion Criteria: * History of severe allergic reaction or anaphylaxis to egg protein or any other component of the Vero cell-derived influenza vaccine or the egg-derived influenza vaccine * Oral temperature of \>= 99.5°F (37.5°C) on the day of vaccination in this study (Note: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date if certain requirements \[in the study protocol\] are met) * Rash or dermatologic condition or tattoos which may interfere with injection site reaction rating * Blood transfusion or immunoglobulins received within 90 days of study entry * Live vaccine received within 4 weeks or inactivated vaccine or subunit vaccine received within 2 weeks of study entry * Previous vaccination against influenza for the 2008/2009 northern hemisphere influenza season * Functional or surgical asplenia (e.g. from a history of hemoglobinopathies, leukemias, or lymphomas) * Diagnosed immunodeficiency as a result of a pathological condition * Pharmacologically induced immunodeficiency as a result of prescribed administration of corticosteroids (e.g., any systemic administration of corticosteroids or an inhaled dose equivalent to 800 mg of beclomethasone dipropionate) or chemotherapeutics or as a result of radiation therapy or any other modality capable of altering normal immunologic response * Known or suspected problem with drug or alcohol abuse * Investigational drug received within 6 weeks prior to study entry or concurrent participating in a clinical study that includes the administration of an investigational product * Subjects who are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

Contacts and locations

Locations

  • Benchmark Research Austin

    Austin, Texas, 78705, United States

  • Benchmark Research Ft. Worth

    Fort Worth, Texas, 76135, United States

  • Benchmark Research San Angelo

    San Angelo, Texas, 76904, United States

  • Benchmark Research San Francisco

    San Francisco, California, 94102, United States

  • Benchmark Research, San Francisco

    Sacramento, California, 95816, United States

  • California Research Foundation

    San Diego, California, 92103-6204, United States

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114, United States

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509, United States

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507, United States

  • Clinical Research Associates, Inc. - Nashville

    Nashville, Tennessee, 37203, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134, United States

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608, United States

  • Heartland Research Associates LLC

    Wichita, Kansas, 67207, United States

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219, United States

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134, United States

  • Omega Medical Research

    Warwick, Rhode Island, 02886, United States

  • Palmetto Medical Research

    Mt. Pleasant, South Carolina, 29464, United States

  • Pi-Coor Clinical Research

    Fairfax, Virginia, 22030, United States

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712, United States

  • Radiant Research, Inc.

    St Louis, Missouri, 63141, United States

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760, United States

  • Research Across America

    Plano, Texas, 75093, United States

  • Rochester Clinical Research Inc.

    Rochester, New York, 14609, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • University Clinical Research, Inc.

    Pembroke Pines, Florida, 33024, United States

  • Vince and Associates Clinical Research

    Overland Park, Kansas, 66212, United States

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612, United States

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