This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
Centro Clínico La Quinta
Guatemala City, Guatemala City, Guatemala
Clínicas Dr. Rafael Montiel
Guatemala City, Guatemala City, Guatemala
Dr. Carlos Fernando Grazioso Aragón
Guatemala City, Guatemala City, Guatemala
Fundación Pediátrica Guatemalteca
Guatemala City, Guatemala City, Guatemala
To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
Time frame: 211 days
To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.
Time frame: 211 days
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Hospital Infantil de Infectologia y rehabilitacion
Guatemala City, Guatemala City, Guatemala