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Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)

NCT01959945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2016-09-23

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Flublok® Quadrivalent Influenza Virus Vaccine

Intramuscular (Relevant year formulation)

BIOLOGICAL

Fluarix Quadrivalent® Influenza Virus Vaccine

Intramuscular (Relevant year formulation)

Sponsors & Collaborators

  • Protein Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Lisa Dunkle, MD · Protein Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01959945 on ClinicalTrials.gov