1,556
Participants
Start Date
March 22, 2018
Primary Completion Date
October 22, 2019
Study Completion Date
October 22, 2019
Study group - quadrivalent recombinant hemagglutinin influenza vaccine
Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
Control group - quadrivalent inactivated influenza vaccine
Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
Clinical Research Institute Darwin, Mexico City
Clinical Research Institute Saltillo, Saltillo
Centro de Investigacion Clinica del Pacifico, Acapulco de Juárez
AMIC Pachuca, Pachuca
Instituto Jalisciencie de Metabolismo, Guadalajara
AINPAD Morelia, Morelia
JM Research, Cuernavaca
UDEP Puebla, Puebla City
Centro Especializado en Investigación Clínica CEIC, Veracruz
Instituto Nacional de Pediatria, Mexico City
CEMDEC, Mexico City
Lead Sponsor
Collaborators (2)
EPIC Research CRO
INDUSTRY
ILS Clinical Research
UNKNOWN
Q Square Solutions
UNKNOWN
Laboratorios Liomont
INDUSTRY