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Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

13. december 2012 opdateret af: Sanofi

Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

729

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
      • Hoover, Alabama, Forenede Stater, 35216
      • Mobile, Alabama, Forenede Stater, 36608
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85710
    • Connecticut
      • Milford, Connecticut, Forenede Stater, 06460
    • Florida
      • Pinellas Park, Florida, Forenede Stater, 33781
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
      • Springfield, Missouri, Forenede Stater, 65802
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
      • Raleigh, North Carolina, Forenede Stater, 27609
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45249
    • Pennsylvania
      • Bensalem, Pennsylvania, Forenede Stater, 19020
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
    • South Carolina
      • Mt Pleasant, South Carolina, Forenede Stater, 29464

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 til 49 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria :

  • Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination

Exclusion Criteria :

  • Subject currently breast-feeding.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
  • Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
  • Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
  • Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
  • Receipt of blood or blood-derived products in the 3 months preceding vaccination.
  • Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
  • History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
  • Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
  • Planned receipt of any other 2007-2008 influenza vaccine.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • History of Guillain-Barré syndrome
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the 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: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
Biologisk: Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
Eksperimentel: Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
Biologisk: Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
Aktiv komparator: Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
Biologisk: Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Andre navne:
  • Fluzone® (2007-2008 formulation)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Tidsramme: Days 0 and 21 post-vaccination
Days 0 and 21 post-vaccination
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Tidsramme: Day 21 post-vaccination
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Day 21 post-vaccination
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Tidsramme: Day 21 post-vaccination

Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.

Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Day 21 post-vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Tidsramme: Day 0 up to Day 7 post-vaccination

Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.

Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
Day 0 up to Day 7 post-vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

Sanofi

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.

Hjælpsomme links

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 2007

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. november 2008

Datoer for studieregistrering

Først indsendt

13. februar 2009

Først indsendt, der opfyldte QC-kriterier

13. februar 2009

Først opslået (Skøn)

18. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. december 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GCE03

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 .

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