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A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)

NCT02121782 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-08-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in Korean healthy adults.

The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV) including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B). However, two antigenically distinct lineages of influenza B (Victoria and Yamagata) co-circulate annually in the United States. Predicting which lineage of influenza B will predominate during a season is challenging, and cross-protection by immunization against the other lineage is expected to be low. One proposed alternative is to produce a quadrivalent influenza vaccine (QIV) including an influenza B virus from each of the two circulating lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season (northern hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the additional public health benefit compared with traditional TIV.

Conditions

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine

GC3110A, 0.5ml, intramuscular, a single dosing at Day 1

BIOLOGICAL

Trivalent influenza vaccine

GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Woo Joo KIM, M.D., Ph.D. · Korea University Guro Hospital

  • Chang-Hee Lee, M.D. · Green Cross Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • South Korea

Study Locations

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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 NCT02121782 on ClinicalTrials.gov