- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03893669
Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
25. März 2019 aktualisiert von: SK Chemicals Co., Ltd.
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
Studientyp
Interventionell
Einschreibung (Tatsächlich)
100
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Guro-gu
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Seoul, Guro-gu, Korea, Republik von, 153-703
- Korea University Guro Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 59 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- 20 to <60 years of age
- able and willing to give written informed consent prior to study entry
- if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Immunodeficiency disease
- history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- thrombocytopenia or Coagulation disorders
- experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- receipt of Immunosuppressants or Immunomodulators within the past 3 months
- receipt of blood products or immunoglobulin within the past 3 months
- received influenza vaccine within the past 6 months
- received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- participation on another clinical trial within 1 month prior to the study vaccination
- history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- any chronic diseases that interfere with the clinical trial or Malignant tumors
- pregnant or breastfeeding
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Group 1
NBP607 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
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Aktiver Komparator: Group 2
Agrippal 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Incidence rate of solicited local adverse events (AEs)
Zeitfenster: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Incidence rate of solicited systemic AEs
Zeitfenster: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Incidence rate of unsolicited AEs
Zeitfenster: Within 21 days after vaccination
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All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
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Within 21 days after vaccination
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Pulse rate at each visit
Zeitfenster: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Blood pressure(systolic/diastolic) at each visit
Zeitfenster: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Body temperature at each visit
Zeitfenster: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
Zeitfenster: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Rate of normal/abnormal results in physical examination at each visit
Zeitfenster: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
Zeitfenster: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Comparisons within each group between pre-/post- vaccination were summarized and presented.
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Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Zeitfenster: 21-28 days after vaccination
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The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
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21-28 days after vaccination
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Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Zeitfenster: 21-28 days after vaccination
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The mean increase in geometric mean HI titer
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21-28 days after vaccination
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Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
Zeitfenster: 21-28 days after vaccination
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The proportion of subjects with post-vaccination HI titers of ≥1:40
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21-28 days after vaccination
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Woo Joo Kim, Ph.D., Korea University Guro Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2012
Primärer Abschluss (Tatsächlich)
1. Oktober 2012
Studienabschluss (Tatsächlich)
1. November 2012
Studienanmeldedaten
Zuerst eingereicht
12. Dezember 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. März 2019
Zuerst gepostet (Tatsächlich)
28. März 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. März 2019
Zuletzt verifiziert
1. Oktober 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NBP607_Flu_I_2012
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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