Status:
COMPLETED
Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics
Lead Sponsor:
Protein Sciences Corporation
Conditions:
Influenza
Eligibility:
All Genders
6-59 years
Phase:
PHASE1
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00336453
Start Date
October 1 2006
End Date
July 1 2007
Last Update
December 17 2009
Active Locations (3)
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1
Kentucky pediatric /Adult Research
Bardstown, Kentucky, United States, 40004
2
Saint Louis University
St Louis, Missouri, United States, 63110
3
Primary Physicians Research
Pittsburgh, Pennsylvania, United States, 15241