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Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

NCT02467842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1503

Last updated 2020-05-08

Study results available
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Summary

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.

Conditions

Interventions

BIOLOGICAL

NBP607-QIV

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria

BIOLOGICAL

NBP607-Y

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata

BIOLOGICAL

NBP607-V

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Woo Joo Kim, MD, PhD · Korea University Guro Hospital

  • Won Suk Choi, MD, PhD · Korea University

  • Seong-Heon Wie, MD, PhD · Catholic University St. Vincent's Hospital

  • Jin Soo Lee, MD, PhD · Inha University Hospital

  • Jacob Lee, MD, PhD · Hallym University Kangnam Sacred Heart Hospital

  • Shin Woo Kim, MD, PhD · Kyungpook University Hospital

  • Hye Won Jeong, MD · Chungbuk University Hospital

  • Sook-In Jung, MD · Chonnam University Hospital

  • Yeon-Sook Kim, MD, PhD · Chungnam University Hospital

  • Heung Jeong Woo, MD, PhD · Hallym University Dongtan Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2015-05-31

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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 NCT02467842 on ClinicalTrials.gov