Evaluation of a Recombinant Quadrivalent Influenza Vaccine Versus a Marketed Quadrivalent Inactivated Influenza Vaccine in Children 3 to 17.

PHASE3CompletedINTERVENTIONAL
Enrollment

1,556

Participants

Timeline

Start Date

March 22, 2018

Primary Completion Date

October 22, 2019

Study Completion Date

October 22, 2019

Conditions
Influenza, Human
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (11)

11590

Clinical Research Institute Darwin, Mexico City

25020

Clinical Research Institute Saltillo, Saltillo

39670

Centro de Investigacion Clinica del Pacifico, Acapulco de Juárez

42070

AMIC Pachuca, Pachuca

44670

Instituto Jalisciencie de Metabolismo, Guadalajara

58070

AINPAD Morelia, Morelia

62290

JM Research, Cuernavaca

72160

UDEP Puebla, Puebla City

94290

Centro Especializado en Investigación Clínica CEIC, Veracruz

04530

Instituto Nacional de Pediatria, Mexico City

06100

CEMDEC, Mexico City

All Listed Sponsors
collaborator

EPIC Research CRO

INDUSTRY

collaborator

ILS Clinical Research

UNKNOWN

collaborator

Q Square Solutions

UNKNOWN

lead

Laboratorios Liomont

INDUSTRY