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

25. mars 2019 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 59 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SK Chemicals Co., Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2012

Primær fullføring (Faktiske)

1. oktober 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

12. desember 2012

Først innsendt som oppfylte QC-kriteriene

25. mars 2019

Først lagt ut (Faktiske)

28. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mars 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2019

Sist bekreftet

1. oktober 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NBP607_Flu_I_2012

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