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A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

18. oktober 2017 opdateret af: Seqirus

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1313

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35802
        • Study Site
    • California
      • San Diego, California, Forenede Stater, 92108
        • Study Site
    • Florida
      • Melbourne, Florida, Forenede Stater, 32935
        • Study Site
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61602
        • Study Site
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46601
        • Study Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Study Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Study Site
      • Rockville, Maryland, Forenede Stater, 20850
        • Study Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Study Site
      • Fort Worth, Texas, Forenede Stater, 76135
        • Study Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Study Site

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:

  • Male or female aged 18 and older, inclusive, at the time of providing informed consent.
  • Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study 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: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CSL425 (30 mcg)
30 mcg hæmagglutinin-antigen pr. dosis. 0,5 ml intramuskulær injektion i deltoidregionen af ​​armen på dag 0 og dag 21
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Eksperimentel: CSL425 (7.5 mcg)
7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Eksperimentel: CSL425 (15 mcg)
15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
Biologisk: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Placebo komparator: Placebo
Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
Biologisk: Placebo
Vaccine diluent, thimerosal 0.01% (weight/volume).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seroconversion Rate 21 Days After the First Vaccination
Tidsramme: 21 days after the first vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the first vaccination
Seroconversion Rate 21 Days After the Second Vaccination
Tidsramme: 21 days after the second vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the second vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
Tidsramme: 21 days after the first vaccination
21 days after the first vaccination
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
Tidsramme: 21 days after the second vaccination
21 days after the second vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Tidsramme: During the 7 days after the first vaccination
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
During the 7 days after the first vaccination
Duration of Solicited Local Adverse Events After the First Vaccination
Tidsramme: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
Tidsramme: Up to 180 days after the last vaccination
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Tidsramme: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Unsolicited adverse event (UAE) grading:

Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.

Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Samarbejdspartnere og efterforskere

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

Sponsor

Seqirus

Efterforskere

  • Studieleder: Director, Vaccines Clinical Development, Seqirus

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. august 2009

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

12. august 2009

Først indsendt, der opfyldte QC-kriterier

12. august 2009

Først opslået (Skøn)

13. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSLCT-CAL-09-61

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 CSL425

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner