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Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480998
First Posted: June 25, 2015
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.
  Purpose
This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age.

Condition Intervention Phase
Influenza, Human Biological: IL-YANG Flu Vaccine QIV 0.5mL Biological: IL-YANG Flu Vaccine TIV 0.5mL Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects

Resource links provided by NLM:


Further study details as provided by Il-Yang Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Seroconversion rate [ Time Frame: 28 days ]
    Percentage of subjects achieving seroconversion* for HI antibody after vaccination

  • Seroprotection rate [ Time Frame: 28 days ]
    Percentage of subjects achieving seroprotection* for HI antibody after vaccination


Secondary Outcome Measures:
  • GMT [ Time Frame: 28 days ]
    Geometric Mean Titer

  • GMR [ Time Frame: 28 days ]
    Geometric Mean Ratio

  • Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40 [ Time Frame: 28 days ]
    Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40 who have achieved a minimum four-fold rise in HI antibody titer post-vaccination


Enrollment: 84
Study Start Date: February 2015
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IL-YANG Flu Vaccine QIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
Biological: IL-YANG Flu Vaccine QIV 0.5mL
Active Comparator: IL-YANG Flu Vaccine TIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
Biological: IL-YANG Flu Vaccine TIV 0.5mL

Detailed Description:

This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial.

During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women 19 to < 65 years of age at screening
  • Body weight within ±20% of ideal body weight at screening
  • Women of childbearing potential must have a negative serum beta-hCG at visit 2; and agree to use a proper contraceptive method for 1 month after vaccination (starting from 3 months before screening), using a medication or device that does not have any drug-interaction with the investigational product.
  • Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted no later than 28 days prior to vaccination
  • Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements

Exclusion Criteria:

  • Subject with known allergy to eggs, chicken, or any components of the investigational product
  • Subjects who had received an influenza vaccine within the last 6 months prior to study entry
  • Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL
  • Subjects who have concurrent or a past history of, immune deficiency disease
  • Subject with a history of Guillain-Barre syndrome
  • Subject with hemophilia or thrombocytopenia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
  • Subjects with known allergy to a drug, food or latex, who had a history of anaphylaxis
  • Subjects who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the investigational product or symptoms of suspected acute disease within 14 days prior to administration of the investigational product
  • Subjects who had received another vaccine within 28 days before administration of the investigational product or are planning to receive another vaccine during the study.
  • Subjects who had participated in another clinical trial within the 30 days before administration of the investigational product.
  • Subjects who had previously received blood-derived products (including immunoglobulin) within the last 3 months prior to administration of the Investigational product, or are scheduled to receive a treatment with blood-derived products during the study
  • Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose steroid therapy within the last 6 months prior to administration of the study
  • Subjects with a history of drug abuse within the last 6 months prior to vaccination, or is suspected of drug abuse
  • Subjects with excessive consumption of caffeine, alcohol, or tobacco
  • Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02480998     History of Changes
Other Study ID Numbers: IY_IFEZ_Q120
First Submitted: June 11, 2015
First Posted: June 25, 2015
Last Update Posted: May 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs