Influenza Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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