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

NCT02121782 | Completed Phase 1 DMC

• 1 other identifier: GC3110A_P1/2a
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Influenza

Keywords

QIV; Quadrivalent Influenza Vaccine; Influenza vaccine; Vaccination

Outcome Measures

Primary Outcomes (4)

• Solicited adverse events following vaccination

  Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, arthralgia.

  Day 1 up to 7 Days post vaccination

• Unsolicited adverse events following vaccination

  It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

  Day 1 up to 22 Days post vaccination

• Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain

  Day 22 post vaccination

• Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain

  Day 22 post vaccination

Secondary Outcomes (2)

• Abnormalities in physical examination, vital signs, and/or clinical laboratory tests

  Day 22 post vaccination

• GMT(geometric mean titers) for each strain

  Day 22 post vaccination

Study Arms (3)

Quadrivalent influenza vaccine(Part A)

EXPERIMENTAL

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

Biological: Quadrivalent influenza vaccine

Quadrivalent influenza vaccine(Part B)

EXPERIMENTAL

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

Biological: Quadrivalent influenza vaccine

Trivalent influenza vaccine(Part B)

ACTIVE COMPARATOR

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

Biological: Trivalent influenza vaccine

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

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

Also known as: GC3110A

Quadrivalent influenza vaccine(Part A); Quadrivalent influenza vaccine(Part B)

Trivalent influenza vaccine BIOLOGICAL

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

Also known as: GC Flu Pre-filled Syringe Inj.

Trivalent influenza vaccine(Part B)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Given written informed consent
• Healthy Korean adults (age: between over 19 and under 65)
• Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
• Those who are able to comply with the requirements for the study

You may not qualify if:

• Inability in written/verbal communication
• Subjects who have participated in other interventional study within 30 days
• Alcohol or drug abuse within 6 months
• Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
• Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
• Hypersensitivity with drug or active ingredient
• Disorders in immune function
• History of Guillain-Barré syndrome
• Disease/medications which are likely to cause any severe bleeding
• Active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination
• Oral temperature \>38.0 ℃ at the vaccination day
• Erythema, tattoo, injury at shoulder (vaccination site)
• Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
• Influenza vaccination within 6months
• Any vaccination within 30 days

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Woo Joo KIM, M.D., Ph.D.

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Chang-Hee Lee, M.D.

  Green Cross Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 24, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

KR (1)