Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Adults

NCT02154308 | Completed Phase 3

• 1 other identifier: IY_IFEZ_AD_301
• Study Type: interventional
• Target: 787
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.

Conditions

Healthy

Keywords

Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Solicited local & general Adverse Event, Unsolicited Adverse Event

  Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia

  up to Day28(+7)

• Percentage of subjects achieving seroconversion and seroprotection for HI antibody after administration of the study vaccine

  Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer (Case 2). Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40

  up to Day28(+7)

Secondary Outcomes (3)

• Physical examination finding, vital signs

  Day28(+7)

• Geometric Mean Titer (GMT) of HI antibody titer before vaccination and after vaccination

  Day28(+7)

• Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer

  Day28(+7)

Study Arms (1)

IL-YANG influenza vaccine

EXPERIMENTAL

IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL

Interventions

IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL BIOLOGICAL

IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection

IL-YANG influenza vaccine

Eligibility Criteria

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

You may qualify if:

• Healthy man and woman 18 years of age or older
• Woman of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at screening
• Subject who was given, and fully understood, the information about the study, made a voluntary decision, and provided written informed consent, to participate in the study and comply with all applicable study requirements.

You may not qualify if:

• Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine
• Subject who had received an influenza vaccine within the last 6 months
• Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
• Subject who had participated in blood donation within 1 week prior to vaccination, or is planning to participate in blood donation from Day 1 until Month 7 post-vaccination.
• Subject with a history of Guillain-Barre syndrome
• Subject with Down's syndrome or cytogenetic disorders.
• Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
• Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
• Subject who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine
• Subject who had received any product containing acetylsalicylic acid or aspirin within 14 days prior to administration of the study vaccine
• Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
• Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
• Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
• Subject who had participated in another experimental study within 30 days prior to administration of the study vaccine
• Woman of childbearing potential at screening or woman who plans to become pregnant during the study. A woman of childbearing potential must have a negative pregnancy test, and, unless surgically sterile, must use an effective method of contraception throughout the study to be eligible for the study. Periodic abstinence and withdrawal are not considered as acceptable methods of contraception. Use of hormonal contraceptives is not allowed.

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

Incheon St. Mary's Hospital, The Catholic University of Korea etc, Total 10 hospitals.

Seoul Etc, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• IL-YANG PHARM

  IL-YANG Pharmaceutical Co.,LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

KR (1)