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InfluenzaPhase 1/2NCT00336453

Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics

A Phase 1/2 study testing Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 3 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 was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months. Read more about this study

Who is it for?
Ages 6 to 59 monthsHealthy 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
156 participants
Where
3 sitesUnited States
Study dates
Oct 2006to Jul 2007
Phase
Phase 1/2
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 6 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The subject was:
  • aged 6-59 months old (inclusive) at enrollment.
  • in good health (and not on any chronic medications), as determined by medical history and a history directed targeted physical examination.
  • naïve for previous influenza vaccination prior to study enrollment.
  • Parents or guardians must:
  • be able to understand and comply with planned study procedures and be available for all study visits.
  • provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Who cannot join

  • a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
  • a history of severe asthma or more than three previous wheezing episodes.
  • be undergoing immunosuppression as a result of an underlying illness or treatment.
  • an active neoplastic disease or a history of any hematologic malignancy.
  • be using oral or parenteral steroids, inhaled steroids or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
  • a history of receiving influenza vaccine or plans during the study to receive influenza vaccine outside the study.
Show all 15Show fewer
  • a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  • received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  • have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
  • a history of severe reactions following immunization.
  • an acute illness, including an axillary temperature greater than 100.0*F, within 3 days prior to vaccination.
  • received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 6-month study period.
  • any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  • a history of Guillain-Barré syndrome.
  • be participating concurrently in another clinical trial (either in active phase or in follow-up phase).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Kentucky pediatric /Adult Research

    Bardstown, Kentucky, 40004

  • Primary Physicians Research

    Pittsburgh, Pennsylvania, 15241

  • Saint Louis University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Evaluation of the Safety, Reactogenicity and Immunogenicity of FluBlok Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly to Healthy Children Aged 6 To 59 Months

The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.

Read the detailed description

Influenza has been identified as a major health problem in young children. Influenza related hospitalizations are very high in children less than 24 months of age and children age 24-59 months have a high rate of medical care utilization due to influenza. Recently, it has been noted that there are deaths attributable to influenza even in previously healthy children. Recent CDC recommendations reflect this growing awareness of the impact of influenza in children and state that virtually all children less than 18 years of age should receive annual influenza vaccination.

Currently available licensed trivalent influenza vaccines (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.

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

  • Influenza VaccinationBiological

    Also called FluBlok, Fluzone, rHA, rHA0

    0.25mL dose for intramuscular injection

Study groups in NCT00336453
Study groupRoleWhat they receive
FluBlok-22.5 μg, 6-35 months oldExperimental6-35 months old, FluBlok-22.5 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
Receives: Biological: Influenza Vaccination
FluBlok-45 μg, 6-35 months oldExperimental6-35 months old, FluBlok-45 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
Receives: Biological: Influenza Vaccination
TIV-7.5 μg, 6-35 months oldActive comparator6-35 months old, 2006-2007 formulation of Fluzone, (sanofi-pasteur, Swiftwater, PA)-7.5 μg of each hemagglutinin antigen: A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Malaysia/2506/2004 like viruses
Receives: Biological: Influenza Vaccination
TIV-15 μg, 36-59 months oldActive comparator36-59 months old, 2006-2007 formulation of Fluzone (sanofi-pasteur, Swiftwater, PA)-15 μg of each hemagglutinin antigen: A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Malaysia/2506/2004 like viruses
Receives: Biological: Influenza Vaccination
FluBlok-45 μg, 36-59 months oldExperimental36-59 months old, FluBlok-45 μg of each recombinant hemagglutinin antigen: 2006-2007 formulation containing A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/05 (H3N2), and B/Ohio/01/05 like viruses
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 healthy children aged 6-59 months

    Measured: influenza season

Secondary outcomes (1)

  1. To compare the immunogenicity after each dose of two different formulations of FluBlok to TIV in healthy children aged 6-35 months and one formulation of FluBlok to TIV in healthy children aged 36-59 months.

    Measured: Day 0, 28, 56

Timeline

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

  1. First posted13 Jun 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2007
  4. Study completionJul 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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336453
Sponsor's protocol ID
PSC02
Status last verified
Dec 2009
First submitted
12 Jun 2006
Last updated
17 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.

    PubMed 19716456

  • 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 1/2 study testing Influenza Vaccination in people with Influenza, run by Protein Sciences Corporation at 3 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 7 inclusion and 15 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 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 healthy children aged 6-59 months (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 NCT00336453, 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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