Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
31. januar 2019 opdateret af: SK Chemicals Co., Ltd.
A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers
This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1.
To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported.
To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 2
- Fase 1
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
19 år til 59 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults aged 19 to 59 years
- Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
- If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Those with Immunodeficiency disease
- Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
- Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection
- Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
- Those with history of receiving blood products or immunoglobulin within the past 3 months
- Those with history of influenza vaccination within the past 6 months
- Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
- Those with history of participation on another clinical trial within 1 month prior to the study vaccination
- Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
- Those with any chronic diseases that interfere with the clinical trial or malignant tumors
- Pregnant or breastfeeding
- Those with 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: NBP607QIV
1 dose of 0.5mL by Intramuscular injection
|
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
|
|
Aktiv komparator: Agrippal
1 dose of 0.5mL by Intramuscular injection
|
Influenza virus surface antigens of three strains(trivalent)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence rate of solicited local adverse events(AEs)
Tidsramme: 7 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. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. |
7 days after vaccination
|
|
Incidence rate of solicited systemic AEs
Tidsramme: 7 days after vaccination
|
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
7 days after vaccination
|
|
Incidence rate of unsolicited AEs
Tidsramme: 21 days after vaccination
|
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
21 days after vaccination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(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
|
|
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
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
|
|
9. 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
17. februar 2014
Primær færdiggørelse (Faktiske)
28. marts 2014
Studieafslutning (Faktiske)
28. marts 2014
Datoer for studieregistrering
Først indsendt
31. januar 2019
Først indsendt, der opfyldte QC-kriterier
31. januar 2019
Først opslået (Faktiske)
1. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NBP607QIV_Flu_I_2013
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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