MedTrace Logo

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

NCT03460743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1556

Last updated 2019-11-13

No results posted yet for this study

Summary

Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17 years of age. Investigational vaccine is indicated for active immunization against influenza A and B for strains contained in the vaccine marketed in the United States for persons 18 years of age or older.

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.

Sponsors & Collaborators

  • EPIC Research CRO

    collaborator INDUSTRY

  • ILS Clinical Research

    collaborator UNKNOWN

  • Q Square Solutions

    collaborator UNKNOWN

  • Laboratorios Liomont

    lead INDUSTRY

Principal Investigators

  • Mercedes Macias, MD · National Institute of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2019-10-22
Completion
2019-10-22
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460743 on ClinicalTrials.gov