At a glance
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Evaluation of the Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Quadrivalent Recombinant Influenza Vaccine,Seasonal Formulation) Administered Intramuscularly to Healthy Children and Adolescents Age 6-17 Years
In Brief
A Phase 3 clinical trial evaluating Flublok® Quadrivalent Influenza Virus Vaccine and Fluarix Quadrivalent® Influenza Virus Vaccine for Influenza. Completed, enrolled 219 participants across 1 site.
Detailed Summary
Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.
Study Details
Timeline
Interventions
Intramuscular (Relevant year formulation)
Intramuscular (Relevant year formulation)