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

• Sponsor: Il-Yang Pharm. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02480998
• Collaborator: (none)
• Enrollment: 84
• Arms: 2
• Duration (Months): 1.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: IL-YANG Flu Vaccine QIV 0.5mL; Biological: IL-YANG Flu Vaccine TIV 0.5mL	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• 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
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Seroconversion Rate [28 days]

   Percentage of subjects achieving seroconversion* for HI antibody after vaccination

2. Seroprotection Rate [28 days]

   Percentage of subjects achieving seroprotection* for HI antibody after vaccination

Secondary Outcome Measures

1. GMR [28 days]

   Geometric Mean Ratio of post vaccination HI geometric mean titers

2. GMT [28 days]

   Geometric Mean Titer of post vaccination HI geometric mean titers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Il-Yang Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Il-Yang Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02480998
• Other Study ID Numbers: IY_IFEZ_Q120
• First Posted: Jun 25, 2015
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

Participant Flow

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL
Period Title: Overall Study
STARTED	56	28
COMPLETED	56	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL	Total
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL	Total of all reporting groups
Overall Participants	56	28	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.77 (7.01)	27.75 (8.48)	27.10 (7.50)
Sex: Female, Male (Count of Participants)
Female	11 19.6%	5 17.9%	16 19%
Male	45 80.4%	23 82.1%	68 81%

Outcome Measures

1. Primary Outcome

Title	Seroconversion Rate
Description	Percentage of subjects achieving seroconversion* for HI antibody after vaccination
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL
Measure Participants	56	28
H1N1	58.93 105.2%	64.29 229.6%
H3N2	64.29 114.8%	53.57 191.3%
B/Yamagata	55.36 98.9%	35.71 127.5%
B/Victoria	46.43 82.9%	14.29 51%

2. Primary Outcome

Title	Seroprotection Rate
Description	Percentage of subjects achieving seroprotection* for HI antibody after vaccination
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL
Measure Participants	56	28
H1N1	94.64 169%	85.71 306.1%
H3N2	96.43 172.2%	82.14 293.4%
B/Yamagata	87.50 156.3%	78.57 280.6%
B/Victoria	78.57 140.3%	64.29 229.6%

3. Secondary Outcome

Title	GMR
Description	Geometric Mean Ratio of post vaccination HI geometric mean titers
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL 56	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL 28
Measure Participants	56	28
H1N1	5.32	8.41
H3N2	6.90	6.73
B/Massachusetts	3.85	2.90
B/Brisbane	3.20	2.00

4. Secondary Outcome

Title	GMT
Description	Geometric Mean Titer of post vaccination HI geometric mean titers
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL	IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL
Measure Participants	56	28
H1N1	128	110.40
H3N2	176.70	128.00
B/Massachusetts	73.36	51.24
B/Brisbane	52.52	36.23

Adverse Events

Arm/Group Title	IL-YANG Flu Vaccine QIV 0.5mL		IL-YANG Flu Vaccine TIV 0.5mL
Arm/Group Description	A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine QIV 0.5mL		A single 0.5mL dose administrated as an intramuscular injection. IL-YANG Flu Vaccine TIV 0.5mL
All Cause Mortality
	IL-YANG Flu Vaccine QIV 0.5mL		IL-YANG Flu Vaccine TIV 0.5mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)
Serious Adverse Events
	IL-YANG Flu Vaccine QIV 0.5mL		IL-YANG Flu Vaccine TIV 0.5mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	IL-YANG Flu Vaccine QIV 0.5mL		IL-YANG Flu Vaccine TIV 0.5mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.