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Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents

NCT02621177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

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 trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

NBP607

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

  • Ui Yoon Choi · Catholic University of Korea Saint Paul's Hospital

  • Chi Eun Oh · Kosin University Gospel Hospital

  • Byung Wook Eun · Eulji General Hospital

  • Taek Jin Lee · CHA University

  • Ki Hwan Kim · Severance Children's Hospital

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

  • Nam Hee Kim · Inje University Ilsan Paik Hospital

  • 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
2013-11-30
Primary Completion
2014-03-31
Completion
2014-07-31

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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 NCT02621177 on ClinicalTrials.gov