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Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

25 marzo 2019 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  1. Assessment of Safety
  2. Assessment of Immunogenicity
  3. Estimated Enrollment: 100

Tipo di studio

Interventistico

Iscrizione (Effettivo)

100

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea, Repubblica di
    • Guro-gu
      • Seoul, Guro-gu, Corea, Repubblica di, 153-703
        • Korea University Guro Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 59 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 20 to <60 years of age
  2. able and willing to give written informed consent prior to study entry
  3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion Criteria:

  1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  2. Immunodeficiency disease
  3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
  4. thrombocytopenia or Coagulation disorders
  5. experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
  6. receipt of Immunosuppressants or Immunomodulators within the past 3 months
  7. receipt of blood products or immunoglobulin within the past 3 months
  8. received influenza vaccine within the past 6 months
  9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
  10. participation on another clinical trial within 1 month prior to the study vaccination
  11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
  12. any chronic diseases that interfere with the clinical trial or Malignant tumors
  13. pregnant or breastfeeding
  14. 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1
NBP607 0.5ml
Biologico: NBP607
1 dose, 0.5ml, Intramuscular (IM) injection
Comparatore attivo: Group 2
Agrippal 0.5ml
Biologico: Agrippal
1 dose, 0.5ml, Intramuscular (IM) injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence rate of solicited local adverse events (AEs)
Lasso di tempo: 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.
Within 21 days after vaccination
Incidence rate of solicited systemic AEs
Lasso di tempo: 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.
Within 21 days after vaccination
Incidence rate of unsolicited AEs
Lasso di tempo: 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.
Within 21 days after vaccination
Pulse rate at each visit
Lasso di tempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Blood pressure(systolic/diastolic) at each visit
Lasso di tempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Body temperature at each visit
Lasso di tempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
Lasso di tempo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Rate of normal/abnormal results in physical examination at each visit
Lasso di tempo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
Lasso di tempo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Lasso di tempo: 21-28 days after vaccination
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
21-28 days after vaccination
Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Lasso di tempo: 21-28 days after vaccination
The mean increase in geometric mean HI titer
21-28 days after vaccination
Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
Lasso di tempo: 21-28 days after vaccination
The proportion of subjects with post-vaccination HI titers of ≥1:40
21-28 days after vaccination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SK Chemicals Co., Ltd.

Investigatori

  • Investigatore principale: Woo Joo Kim, Ph.D., Korea University Guro Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2012

Completamento primario (Effettivo)

1 ottobre 2012

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

12 dicembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

25 marzo 2019

Primo Inserito (Effettivo)

28 marzo 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2019

Ultimo verificato

1 ottobre 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NBP607_Flu_I_2012

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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