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

28 juli 2020 bijgewerkt door: Il-Yang Pharm. Co., Ltd.

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

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

84

Fase

  • Fase 2
  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: IL-YANG Flu Vaccine QIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
Actieve vergelijker: IL-YANG Flu Vaccine TIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Seroconversion Rate
Tijdsspanne: 28 days
Percentage of subjects achieving seroconversion* for HI antibody after vaccination
28 days
Seroprotection Rate
Tijdsspanne: 28 days
Percentage of subjects achieving seroprotection* for HI antibody after vaccination
28 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
GMR
Tijdsspanne: 28 days
Geometric Mean Ratio of post vaccination HI geometric mean titers
28 days
GMT
Tijdsspanne: 28 days
Geometric Mean Titer of post vaccination HI geometric mean titers
28 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2015

Primaire voltooiing (Werkelijk)

1 april 2015

Studie voltooiing (Werkelijk)

1 april 2015

Studieregistratiedata

Eerst ingediend

11 juni 2015

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2015

Eerst geplaatst (Schatting)

25 juni 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2020

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2020

Laatst geverifieerd

1 juli 2020

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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