- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01512056
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Tainan, Taiwan, 704
- Rekrytering
- National Cheng Kung University Hospital
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Kontakt:
- Junne Ming Sung, MD
- Telefonnummer: 2594 886-6-2353535
- E-post: jmsung@mail.ncku.edu.tw
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Kontakt:
- Yu Tzu Chang, MD and Msc
- Telefonnummer: 2593 886-6-2353535
- E-post: kangxiemperor@gmail.com
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Huvudutredare:
- Junne Ming Sung, MD
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Underutredare:
- Yu Tzu Chang, MD and Msc
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Underutredare:
- Yi Ching Yang, MD
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Underutredare:
- Meng Te Lin, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change of antibody titer before and after influenza vaccination
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Seroresponse rate
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BR-100-086
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Kliniska prövningar på AdimFlu-S
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National Cheng-Kung University HospitalOkändKronisk njursjukdom | Immunogenicitet och negativa läkemedelseffekter av vacciner InfluensaTaiwan
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Adimmune CorporationAvslutad
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Adimmune CorporationAvslutad
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Adimmune CorporationAvslutad
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Adimmune CorporationAvslutad
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Adimmune CorporationAvslutad
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Adimmune CorporationAvslutad
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National Taiwan University HospitalOkändSerologisk analys | Ny H1N1-influensavaccination | Pediatriska hemato-onkologiska patienterTaiwan