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Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months

NCT03020628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2017-11-01

No results posted yet for this study

Summary

This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6\~35 months.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

NBP607-QIV

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

BIOLOGICAL

NBP607-TIV

For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yun Kyung Kim · Korea University Ansan Hospital

  • Hye Kyung Cho · Gachon University Gil Medical Center

  • Ki Hwan Kim · Incheon St.Mary's Hospital

  • Byung Wook Eun · Eulji General Hospital

  • Yae Jean Kim · Samsung Medical Center

  • Jina Lee · Asan Medical Center

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

  • Hwang Min Kim · Wonju Severance Christian Hospital

  • Nam Hee Kim · Inje University Ilsan Paik Hospital

  • Dae Sun Jo · Chonbuk National University Hospital

  • Eun Young Cho · Chungnam 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
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-03-31
Completion
2017-06-30

Countries

  • South Korea

Study Locations

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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 NCT03020628 on ClinicalTrials.gov