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AzTrials

InfluenzaPhase 3NCT00395174

Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

A Phase 3 study testing Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 7 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 purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Influenza Vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
870 participants
Where
7 sitesUnited States
Study dates
Oct 2006to May 2007
Phase
Phase 3
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Ambulatory adults aged 65 and older
  • Medically stable, as determined by oral temperature <100.0°F, medical history, and targeted physical examination based on medical history
  • Able to understand and comply with planned study procedures
  • Provides written informed consent prior to initiation of any study procedure.

Who cannot join

  • Known allergy to eggs or other vaccine components.
  • Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
  • Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.
  • Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed).
  • Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia
  • History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Show all 14Show fewer
  • Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • History of severe reactions following immunization with influenza virus vaccines.
  • Moderate to severe acute illness or febrile illness (oral temperature greater than 100*F) within 1 week prior to vaccination.
  • Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
  • Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • History of alcohol or drug abuse in the last 5 years.
  • History of Guillain-Barré Syndrome.
  • Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Center of Vaccine Development, Univ. of Maryland

    Baltimore, Maryland, 21201

  • Passport Health Maryland

    Baltimore, Maryland, 21230

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Primary Physicians Research

    Pittsburgh, Pennsylvania, 15241

  • Mayo Clinic College of Medicine

    Rochester, Minnesota, 55905

  • Rochester Medical Center

    Rochester, New York, 14642

  • Passport Health New Jersey

    Shrewsbury, New Jersey, 07702

Other trials in United States

About this study

Official title: Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.

Read the detailed description

Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza.

Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.

Conditions
Influenza
Being tested
Influenza Vaccination
Keywords
Influenza
Medical subject headings
Influenza, Human

What participants receive

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

  • Influenza VaccinationBiological

    Also called FluBlok, Fluzone, rHA, rHA0

    0.5mL dose for intramuscular injection

Study groups in NCT00395174
Study groupRoleWhat they receive
FluBlokExperimentalRecombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio 135μg total
Receives: Biological: Influenza Vaccination
TIV (Fluzone)Active comparatorLicensed trivalent influenza vaccine (TIV): 2005-2006 formulation containing 15μg of each hemagglutinin derived from A/Wisconsin (H3N2), A/New Caledonia (H1N1) and B/Malaysia 45μg total (Fluzone, sanofi pasteur)
Receives: Biological: Influenza Vaccination

What is being measured

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

  1. Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older.

    Measured: influenza season

Secondary outcomes (2)

  1. Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older.

    Measured: influenza season

  2. Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older.

    Measured: influenza season

Timeline

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

  1. First posted2 Nov 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMay 2007
  4. Study completionMay 2007

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
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
870 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00395174
Sponsor's protocol ID
PSC03
Status last verified
Dec 2009
First submitted
30 Oct 2006
Last updated
17 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Keitel WA, Treanor JJ, El Sahly HM, Gilbert A, Meyer AL, Patriarca PA, Cox MM. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or =65 years old. Vaccine. 2009 Dec 11;28(2):379-85. doi: 10.1016/j.vaccine.2009.10.037. Epub 2009 Oct 29.

    PubMed 19879222

  • Rajendran M, Nachbagauer R, Ermler ME, Bunduc P, Amanat F, Izikson R, Cox M, Palese P, Eichelberger M, Krammer F. Analysis of Anti-Influenza Virus Neuraminidase Antibodies in Children, Adults, and the Elderly by ELISA and Enzyme Inhibition: Evidence for Original Antigenic Sin. mBio. 2017 Mar 21;8(2):e02281-16. doi: 10.1128/mBio.02281-16.

    PubMed 28325769

  • Nachbagauer R, Choi A, Izikson R, Cox MM, Palese P, Krammer F. Age Dependence and Isotype Specificity of Influenza Virus Hemagglutinin Stalk-Reactive Antibodies in Humans. mBio. 2016 Jan 19;7(1):e01996-15. doi: 10.1128/mBio.01996-15.

    PubMed 26787832

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 7 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 14 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 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older. (time frame: influenza season). 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 NCT00395174, 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 Dec 2009.

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