- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01512056
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital
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Kontakt:
- Junne Ming Sung, MD
- Telefonnummer: 2594 886-6-2353535
- E-mail: jmsung@mail.ncku.edu.tw
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Kontakt:
- Yu Tzu Chang, MD and Msc
- Telefonnummer: 2593 886-6-2353535
- E-mail: kangxiemperor@gmail.com
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Ledende efterforsker:
- Junne Ming Sung, MD
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Underforsker:
- Yu Tzu Chang, MD and Msc
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Underforsker:
- Yi Ching Yang, MD
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Underforsker:
- Meng Te Lin, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Males and non-pregnant females and aged more than 18 years;
- Willing and able to adhere to visit schedules and all study requirements;
- Subjects read and signed the study-specific informed consent.
Exclusion Criteria:
- Subject or his/her family is employed by the participated hospital;
- Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- Personal or family history of Guillain-Barré Syndrome;
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
- Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- Female subjects who are pregnant during the study.
- Patients who receive hemodialysis therapy less than 3 months.
- Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- Immunodeficiency, or under immunosuppressive treatment.
- Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Any severe illness needed to be hospitalization within three months.
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: the immunogenicity profiles of the AdimFlu-S
Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later. Negative control group: dialysis patients who refused to receive influenza vaccination. |
All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3).
Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
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Ingen indgriben: The safety outcome of the vaccine
Any adverse effect, including systemic or local site, will be recorded during the study period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of antibody titer before and after influenza vaccination
Tidsramme: 18 weeks
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The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40.
MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination.
The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
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18 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Seroresponse rate
Tidsramme: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.
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0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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Seroresponse rate
Tidsramme: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination. Geometric mean folds increase in HI or micro-NT titer. |
0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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the safety and tolerability profiles of the vaccine
Tidsramme: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
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evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.
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0, 3 week, 6 weeks, 9 weeks, 18 weeks
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BR-100-086
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Kliniske forsøg med AdimFlu-S
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National Cheng-Kung University HospitalUkendtKronisk nyresygdom | Immunogenicitet og skadelig lægemiddeleffekt af vacciner InfluenzaTaiwan
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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Adimmune CorporationAfsluttet
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National Taiwan University HospitalUkendtSerologisk analyse | Ny H1N1-influenzavaccination | Pædiatriske hæmato-onkologiske patienterTaiwan
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Adimmune CorporationAfsluttet