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Safety and Immunogenicity of FluBlok in Pediatrics
This study is ongoing, but not recruiting participants.
Sponsored by: Protein Sciences Corporation
Information provided by: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00336453
  Purpose

This Phase I/II study will evaluate the Safety, Reactogenicity and Immunogenicity of FluBlØk™ Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, Administered Intramuscularly to Healthy Children Aged 6 to 59 Months

Approximately 300 healthy children, aged 6-59 months inclusive who meet the Inclusion/Exclusion Criteria, will be enrolled in this study. The target population is expected to reflect the community at large at each of the study sites. The Study Population will be evaluated as a whole and as two sub-groups:

  • All study participants aged 6 to 35 months
  • All study participants aged 36 to 59 months

The purpose of this study is to determine the safety, reactogenicity and immunogenicity of FluBlØk formulated as detailed above relative to TIV.

Our objective is to determine the optimal dose and dosing regime of FluBlØk for the two age groups participating in the study.


Condition Intervention Phase
Influenza
Biological: FluBlok
Phase I
Phase II

MedlinePlus related topics: Children's Health Flu
Drug Information available for: Influenza Vaccines Fluvirin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Safety, Reactogenicity and Immunogenicity of FluBlØk™ Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly To Healthy Children Aged 6 To 59 Months

Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • To compare safety, reactogenicity and immunogenicity after each dose of two different formulations of FluBlØk to TIV in healthy children aged 6-35 months and one formulation of FluBlØk to TIV in healthy children aged 36-59 months.

Estimated Enrollment: 300
Study Start Date: October 2006
Estimated Study Completion Date: April 2007
Detailed Description:

The study will be conducted as a randomized, prospective, parallel group, active controlled, observer and subject blinded trial. This study is a randomized, double-blinded, Phase I/II multi-center clinical trial to evaluate the safety, reactogenicity, and immunogenicity of FluBlØk or TIV in healthy children, aged 6-59 months inclusive. Subjects will be stratified by age either 6 to 35 months old inclusive or 36 to 59 months old inclusive. Within their age division, subjects will be randomized to receive either FluBlØk or TIV as noted in the table below. Subjects and staff will be blinded to vaccine product and dose given. FluBlØk will be compared to TIV for safety, reactogenicity and immunogenicity (measured by HAI antibody titer at day 28 and day 56). Subjects’ parents or guardians will be given a memory aid for reactogenicity events and data collected by a phone call one week following each vaccination. A final safety call will be made at approximately six months after the first vaccination.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in this study and must also meet these criteria prior to receiving each vaccination:

  1. The subject must be:

    1. aged 6-59 months old (inclusive) at enrollment.
    2. in good health (and not on any chronic medications), as determined by medical history and a history directed targeted physical examination.
    3. naïve for previous influenza vaccination prior to study enrollment.
  2. Parents or guardians must:

    1. be able to understand and comply with planned study procedures and be available for all study visits.
    2. provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria:

Subjects must not have or meet any of the following exclusion criteria at baseline or prior to each injection, or they will be excluded from study participation:

  1. a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
  2. a history of severe asthma or more than three previous wheezing episodes.
  3. be undergoing immunosuppression as a result of an underlying illness or treatment.
  4. an active neoplastic disease or a history of any hematologic malignancy.
  5. 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.
  6. a history of receiving influenza vaccine or plans during the study to receive influenza vaccine outside the study.
  7. a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  8. received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
  9. 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).
  10. a history of severe reactions following immunization.
  11. an acute illness, including an axillary temperature greater than 100F, within 3 days prior to vaccination.
  12. 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.
  13. 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.
  14. a history of Guillain-Barré syndrome.
  15. be participating concurrently in another clinical trial (either in active phase or in follow-up phase).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336453

Locations
United States, Kentucky
Kentucky pediatric /Adult Research
Bardstown, Kentucky, United States, 40004
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
Sponsors and Collaborators
Protein Sciences Corporation
Investigators
Principal Investigator: James C King, MD University of Maryland
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: PSC02
Study First Received: June 12, 2006
Last Updated: March 26, 2007
ClinicalTrials.gov Identifier: NCT00336453  
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Influenza

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009