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InfluenzaPhase 3NCT00566345

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

A Phase 3 study testing Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) and Phosphate buffered saline in people with Influenza, run by Alachua Government Services, Inc. at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) and Phosphate buffered saline
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,670 participants
Where
34 sitesUnited States
Study dates
Nov 2007to Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female subjects who
  • are 18 to 49 years of age, inclusive, on the day of screening
  • have an understanding of the study, agree to its provisions 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 of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Who cannot join

  • Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):
  • 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
Show all 24Show fewer
  • chronic metabolic disorder (including diabetes mellitus)
  • immunosuppression (including immunosuppression caused by medications 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 a 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
  • Subjects are also excluded if they
  • are unable to lead an independent life as a result of either physical or mental handicap
  • have a history of severe allergic reactions or anaphylaxis
  • have an 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 provided: 1.) oral temperature has decreased to < 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/exclusion criteria are met, 3.) the rescheduled date is no more than 14 days past the initial screening date, 4.) the study site is still enrolling subjects]
  • have a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
  • have received a blood transfusion or immunoglobulins within 90 days of study entry
  • have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of study entry
  • have previously been vaccinated against influenza for the 2007/2008 northern hemisphere influenza season
  • have functional or surgical asplenia
  • have a known or suspected problem with alcohol or drug abuse
  • were 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
  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Study site

    Anaheim, California

  • Study site

    Austin, Texas

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, Maryland

  • Study site

    Dallas, Texas

  • Study site

    Fort Worth, Texas

  • Study site

    Goose Creek, South Carolina

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Las Vegas, Nevada

  • Study site

    Lenexa, Kansas

  • Study site

    Lexington, Kentucky

  • Study site

    Metairie, Louisiana

  • Study site

    Nashville, Tennessee

  • Study site

    Norfolk, Virginia

  • Study site

    Omaha, Nebraska

  • Study site

    Overland Park, Kansas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Plano, Texas

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Angelo, Texas

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    South Miami, Florida

  • Study site

    Spartanburg, South Carolina

  • Study site

    St Louis, Missouri

  • Study site

    Tucson, Arizona

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)

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.

Conditions
Influenza
Being tested
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived), Phosphate buffered saline
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)Biological

    Trivalent, non-adjuvanted vaccine; dose: 0.5 ml

  • Phosphate buffered salineOther

    Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Study groups in NCT00566345
Study groupRoleWhat they receive
Influenza vaccineExperimentalVero-cell derived influenza vaccine
Receives: Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
PlaceboPlacebo comparatorPhosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Receives: Other: Phosphate buffered saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens

    Measured: 21 days to 180 days after the date of vaccination

  2. The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values

    Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.

    Measured: 21 Days after vaccination

Secondary outcomes (1)

  1. Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination

    Measured: During the entire 180-day follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,670 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00566345
Sponsor's protocol ID
720703
Status last verified
Jul 2023
First submitted
30 Nov 2007
Last updated
17 Oct 2023
Data monitoring committee
Yes

Publications

  • Ehrlich HJ, Singer J, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Portsmouth D, Kistner O, Barrett PN. A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals. Clin Infect Dis. 2012 Apr;54(7):946-54. doi: 10.1093/cid/cir959. Epub 2012 Jan 19.

    PubMed 22267715

  • Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.

    PubMed 22172502

  • Barrett PN, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Kistner O, Ehrlich HJ. Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2011 Feb 26;377(9767):751-9. doi: 10.1016/S0140-6736(10)62228-3. Epub 2011 Feb 15.

    PubMed 21329971

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) and Phosphate buffered saline in people with Influenza, run by Alachua Government Services, Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (time frame: 21 days to 180 days after the date of vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566345, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

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