- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02480998
Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: IL-YANG Flu Vaccine QIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
|
|
|
Comparateur actif: IL-YANG Flu Vaccine TIV 0.5mL
A single 0.5mL dose administrated as an intramuscular injection.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seroconversion Rate
Délai: 28 days
|
Percentage of subjects achieving seroconversion* for HI antibody after vaccination
|
28 days
|
|
Seroprotection Rate
Délai: 28 days
|
Percentage of subjects achieving seroprotection* for HI antibody after vaccination
|
28 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
GMR
Délai: 28 days
|
Geometric Mean Ratio of post vaccination HI geometric mean titers
|
28 days
|
|
GMT
Délai: 28 days
|
Geometric Mean Titer of post vaccination HI geometric mean titers
|
28 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IY_IFEZ_Q120
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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