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Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

NCT02621164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2015-12-03

No results posted yet for this study

Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

NBP607-QIV

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

BIOLOGICAL

Agrippal S1

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yun Kyung Kim · Korea University Ansan Hospital

  • Byung Wook Eun · Eulji General Hospital

  • Taek Jin Lee · CHA University

  • Jina Lee · Asan Medical Center

  • Ki Hwan Kim · Severance Children's Hospital

  • Dong Ho Kim · Korea Institute of Radiological and Medical Science

  • Dae Sun Jo · Chonbuk National University Hospital

  • Seon Hee Shin · Hallym University Dongtan Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-02-28
Completion
2015-06-30

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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 NCT02621164 on ClinicalTrials.gov