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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

13. januar 2012 opdateret af: National Cheng-Kung University Hospital
The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. 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). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

300

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

      • Tainan, Taiwan, 704
        • Rekruttering
        • National Cheng Kung University Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Junne Ming Sung, MD
        • Underforsker:
          • Yu Tzu Chang, MD and Msc
        • Underforsker:
          • Yi Ching Yang, MD
        • Underforsker:
          • Meng Te Lin, MD

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Males and non-pregnant females and aged more than 18 years;
  2. Willing and able to adhere to visit schedules and all study requirements;
  3. Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

  1. Subject or his/her family is employed by the participated hospital;
  2. Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
  3. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
  4. Personal or family history of Guillain-Barré Syndrome;
  5. An acute febrile illness within 1 week prior to vaccination;
  6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
  7. 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;
  8. Female subjects who are pregnant during the study.
  9. Patients who receive hemodialysis therapy less than 3 months.
  10. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
  11. Immunodeficiency, or under immunosuppressive treatment.
  12. 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);
  13. Receipt of any blood products, including immunoglobulin in the prior 3 months;
  14. Any severe illness needed to be hospitalization within three months.
  15. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Studieplan

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

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
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).
Ingen indgriben: The safety outcome of the vaccine
Any adverse effect, including systemic or local site, will be recorded during the study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of antibody titer before and after influenza vaccination
Tidsramme: 18 weeks
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.
18 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seroresponse rate
Tidsramme: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
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.
0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
Seroresponse rate
Tidsramme: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks

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
the safety and tolerability profiles of the vaccine
Tidsramme: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
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.
0, 3 week, 6 weeks, 9 weeks, 18 weeks

Samarbejdspartnere og efterforskere

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

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. oktober 2011

Primær færdiggørelse (Forventet)

1. marts 2012

Studieafslutning (Forventet)

1. marts 2012

Datoer for studieregistrering

Først indsendt

1. november 2011

Først indsendt, der opfyldte QC-kriterier

13. januar 2012

Først opslået (Skøn)

19. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2012

Sidst verificeret

1. januar 2012

Mere information

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 .

Kliniske forsøg med Influenza

Kliniske forsøg med AdimFlu-S

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