Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
12. april 2016 opdateret af: Sanofi Pasteur, a Sanofi Company
Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.
Primary Objective:
- To demonstrate lot consistency of the Fluzone ID manufacturing process.
- To provide information concerning the immune response of Fluzone ID.
Secondary Objectives:
Safety
- To describe the safety profile of subjects who receive of Fluzone ID.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4292
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Hoover, Alabama, Forenede Stater, 35216
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Huntsville, Alabama, Forenede Stater, 35802
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Mobile, Alabama, Forenede Stater, 36608
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Mesa, Arizona, Forenede Stater, 85213
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Phoenix, Arizona, Forenede Stater, 85014
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Tucson, Arizona, Forenede Stater, 85711
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California
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Fountain Valley, California, Forenede Stater, 92708
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San Diego, California, Forenede Stater, 92103
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Connecticut
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Milford, Connecticut, Forenede Stater, 06460
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Florida
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Melbourne, Florida, Forenede Stater, 32935
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Pembroke Pines, Florida, Forenede Stater, 33024
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Pinellas Park, Florida, Forenede Stater, 33781
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Idaho
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Boise, Idaho, Forenede Stater, 83642
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Illinois
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Chicago, Illinois, Forenede Stater, 60610
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
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Kansas
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Wichita, Kansas, Forenede Stater, 67207
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
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Madisonville, Kentucky, Forenede Stater, 42431
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
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Missouri
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Kansas City, Missouri, Forenede Stater, 64114
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Springfield, Missouri, Forenede Stater, 65802
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St. Louis, Missouri, Forenede Stater, 63104
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108
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New York
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Binghamton, New York, Forenede Stater, 13901
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Endwell, New York, Forenede Stater, 13760
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Rochester, New York, Forenede Stater, 14621
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Rochester, New York, Forenede Stater, 14609
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North Carolina
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Cary, North Carolina, Forenede Stater, 27518
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Raleigh, North Carolina, Forenede Stater, 27609
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45249
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18102
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Bensalem, Pennsylvania, Forenede Stater, 19020
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Rhode Island
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Warwick, Rhode Island, Forenede Stater, 02886
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South Carolina
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Mt. Pleasant, South Carolina, Forenede Stater, 29464
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Austin, Texas, Forenede Stater, 78705
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Fort Worth, Texas, Forenede Stater, 76107
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Fort Worth, Texas, Forenede Stater, 76135
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Galveston, Texas, Forenede Stater, 77555
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San Angelo, Texas, Forenede Stater, 76904
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Utah
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Salt Lake, Utah, Forenede Stater, 84109
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Salt Lake City, Utah, Forenede Stater, 84121
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West Jordan, Utah, Forenede Stater, 84088
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Washington
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Seattle, Washington, Forenede Stater, 98101
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Wisconsin
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Marshfield, Wisconsin, Forenede Stater, 54449
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Castellana Gardens, Carolina, Puerto Rico, 00983
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San Juan, Puerto Rico, 00918
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San Juan, Puerto Rico, 00935
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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 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria :
- Aged 18 to 64 years on the day of vaccination.
- Informed consent form signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.
Exclusion Criteria :
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
- Breast-feeding woman.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
- Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).
- Personal or family history of Guillain-Barré Syndrome.
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 |
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Eksperimentel: Fluzone Intradermal Vaccine Lot 1
Participants will receive a dose of Influenza intradermal vaccine Lot 1
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0,1 ml, intradermal
0,5 ml, intramuskulært
Andre navne:
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Eksperimentel: Fluzone Intradermal Vaccine Lot 2
Participants will receive a dose of Influenza intradermal vaccine Lot 2
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0,1 ml, intradermal
0,5 ml, intramuskulært
Andre navne:
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Eksperimentel: Fluzone Intradermal Vaccine Lot 3
Participants will receive a dose of Influenza intradermal vaccine Lot 3
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0,1 ml, intradermal
0,5 ml, intramuskulært
Andre navne:
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Aktiv komparator: Fluzone Intramuscular Vaccine
Participants will receive a dose of influenza intramuscular vaccine
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0,1 ml, intradermal
0,5 ml, intramuskulært
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
Tidsramme: Baseline (Day 0) and 28 Days post-vaccination
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The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
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Baseline (Day 0) and 28 Days post-vaccination
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Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Tidsramme: 28 Days post-vaccination
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The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination. |
28 Days post-vaccination
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
Tidsramme: Before and 28 Days post-vaccination
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The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroprotection was defined as a HAI antibody titer ≥ 1:40. |
Before and 28 Days post-vaccination
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Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Tidsramme: Day 0 up to 7 Days post vaccination
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Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
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Day 0 up to 7 Days post vaccination
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2008
Primær færdiggørelse (Faktiske)
1. maj 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
13. oktober 2008
Først indsendt, der opfyldte QC-kriterier
13. oktober 2008
Først opslået (Skøn)
15. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FID31
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 .