Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. marts 2019 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republikken, 153-703
        • Korea University Guro Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 59 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1
NBP607 0.5ml
Biologisk: NBP607
1 dose, 0.5ml, Intramuscular (IM) injection
Aktiv komparator: Group 2
Agrippal 0.5ml
Biologisk: Agrippal
1 dose, 0.5ml, Intramuscular (IM) injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence rate of solicited local adverse events (AEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 21-28 days after vaccination
The proportion of subjects with post-vaccination HI titers of ≥1:40
21-28 days after vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

SK Chemicals Co., Ltd.

Efterforskere

  • Ledende efterforsker: Woo Joo Kim, Ph.D., Korea University Guro Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2012

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

12. december 2012

Først indsendt, der opfyldte QC-kriterier

25. marts 2019

Først opslået (Faktiske)

28. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2019

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NBP607_Flu_I_2012

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner