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Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

NCT02344134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1155

Last updated 2015-01-22

No results posted yet for this study

Summary

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.

To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.

To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

NBP607

0.5 mL, intramuscular, a single dose

BIOLOGICAL

Agrippal S1

0.5 mL, intramuscular, a single dose

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Woojoo Kim · Korea University Guro Hospital

  • Seongheon Wie · Saint Vincent's Hospital, Korea

  • Shinwoo Kim · Kyungpook National University Hospital

  • Wonsuk Lee · Korea University Ansan Hospital

  • Jinsoo Lee · Inha University Hospital

  • Jacob Lee · Hallym University Kangnam Sacred Heart Hospital

  • Heungjeong Woo · Dotal 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
2013-09-30
Primary Completion
2013-11-30
Completion
2014-05-31

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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 NCT02344134 on ClinicalTrials.gov