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New Cell-Grown flu vaccine shows promise in large trial

NCT ID NCT00800605

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a new flu vaccine made in cells (instead of eggs) can prevent the flu. About 7,250 adults received either the vaccine or a placebo shot. Researchers then checked for flu infections over 6 months. The goal was to see if the vaccine protects against flu strains that match the vaccine.

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

7,250 people

The number who actually took part.

Start date

Dec 2008

Finished

Jun 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

18 to 49 years

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: * Subject has an understanding of the study * Subject agrees to study provisions * Subject gives written informed consent prior to study entry * Subject is accessible by telephone or electronic mail to receive reminders from the study site * If female and capable of bearing children, subject has a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agrees to employ adequate birth control measures through the first 60 post-vaccination days. Exclusion Criteria: * Subject has any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC, 2008a): * Pregnancy * Chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition) * Chronic renal disorders * Chronic hepatic disorders * Chronic hematological disorders * Chronic metabolic disorder (including diabetes mellitus and thyroid disorders) * Immunosuppression (including immunosuppression caused by medications, congenital etiologies or HIV) * Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders) * Residence in nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions * Household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above * Employment as a health care worker * Subject is unable to lead an independent life as a result of either physical or mental handicap * Subject has a history of severe allergic reactions or anaphylaxis (e.g., urticaria or asthma that is clinically severe) * Subject has an oral temperature of \>= 99.5° F (37.5°C) on the day of vaccination in this study. \[NOTE: A subject meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided that certain requirements \[in the study protocol\] are met) * Subject has a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating * Subject has received a blood transfusion, blood products or immunoglobulins within 90 days of study entry * Subject has received a live vaccine within 4 weeks or inactivated or subunit vaccine within 2 weeks of study entry * Subject has previously been vaccinated against influenza for the 2008/2009 northern hemisphere influenza season * Subject has a functional or surgical asplenia * Subject has a known or suspected problem with alcohol or drug abuse; * Subject was administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product * Subject is 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

  • Advanced Clinical Research

    West Jordan, Utah, 84088, United States

  • Benchmark Research

    Sacramento, California, 95816, United States

  • Benchmark Research

    Metairie, Louisiana, 70006, United States

  • Benchmark Research Austin

    Austin, Texas, 78705, United States

  • Benchmark Research Ft. Worth

    Fort Worth, Texas, 76135, United States

  • Benchmark Research San Angeolo

    San Angelo, Texas, 76904, United States

  • Benchmark Research San Francisco

    San Francisco, California, 94102, United States

  • California Research Foundation

    San Diego, California, 92103, 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

  • Health Concepts

    Rapid City, South Dakota, 57702, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Jean Brown Research / Westside Medical

    Salt Lake City, Utah, 84124, United States

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219, United States

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134, United States

  • Miami Research Associates

    South Miami, Florida, 33143, United States

  • Omega Medical Research

    Warwick, Rhode Island, 02886, United States

  • PI-COOR Clinical Research

    Burke, Virginia, 22015, United States

  • Pharmax Research Clinic

    Miami, Florida, 33126, United States

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712, United States

  • Radiant Research - Cincinnati

    Cincinnati, Ohio, 45249, United States

  • Radiant Research, Inc

    Denver, Colorado, 80239, United States

  • Radiant Research, Inc - Chicago

    Chicago, Illinois, 60654, United States

  • Radiant Research, Inc.

    St Louis, Missouri, 63141, United States

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760, United States

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609, United States

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • Triangle Medical Research Associates

    Raleigh, North Carolina, 27609, 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

More trials for these conditions

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