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Open-Label Influenza Vaccine Evaluation (OLIVE)

3. december 2019 opdateret af: Huong McLean, PhD, Marshfield Clinic Research Foundation

Open-Label, Randomized Study of Immune Response to Licensed Influenza Vaccines in Adults 65-74 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2016-17 and 2017-18)

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

179

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic - Marshfield Center

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

65 år til 74 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.
  • Willing and able to give informed consent prior to study enrollment
  • Able to comply with study requirements.

Exclusion Criteria:

  • Prior receipt of 2016-17 influenza vaccine
  • Current participation in another clinical trial
  • Presence of a contraindication to influenza 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: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: High Dose Influenza Vaccine
This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Biologisk: High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Andre navne:
  • Fluzone HD
Aktiv komparator: Adjuvanted Influenza Vaccine
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
Biologisk: Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
Andre navne:
  • FluAd
Aktiv komparator: Standard Dose Influenza Vaccine+HD
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.
Biologisk: High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
Andre navne:
  • Fluzone HD
Biologisk: Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Andre navne:
  • Fluvirin Standard Dose
Aktiv komparator: Standard Dose Influenza Vaccine +Adj
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Biologisk: Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
Andre navne:
  • FluAd
Biologisk: Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Andre navne:
  • Fluvirin Standard Dose
Aktiv komparator: Standard Dose Influenza Vaccine+Recomb
This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
Biologisk: Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Andre navne:
  • Fluvirin Standard Dose
Biologisk: Recombinant Influenza vaccine
Licensed and FDA approved FluBlok vaccine to be administered to study participants
Andre navne:
  • FluBlok

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
Tidsramme: Year 1, Day 28 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17
Year 1, Day 28 post vaccination
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
Tidsramme: Year 1, Day 182 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17
Year 1, Day 182 post vaccination
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
Tidsramme: Year 1, Day 365 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17
Year 1, Day 365 post vaccination
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
Tidsramme: Year 2, Day 28 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18
Year 2, Day 28 post vaccination
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
Tidsramme: Year 2, Day 182 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18
Year 2, Day 182 post vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
Tidsramme: Year 1, Day 28 post vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17
Year 1, Day 28 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination
Tidsramme: Year 1, Day 182 post vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17
Year 1, Day 182 post vaccination
HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination
Tidsramme: Year 1, Day 365 post vaccination
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17
Year 1, Day 365 post vaccination
MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination
Tidsramme: Year 1, Day 28 post vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17
Year 1, Day 28 post vaccination
MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination
Tidsramme: Year 1, Day 182 post vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17
Year 1, Day 182 post vaccination
MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination
Tidsramme: Year 1, Day 365 post vaccination
Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17
Year 1, Day 365 post vaccination
MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination
Tidsramme: Year 2, Day 28 post vaccination
Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18
Year 2, Day 28 post vaccination
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination
Tidsramme: Year 2, Day 28 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18
Year 2, Day 28 post vaccination
HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination
Tidsramme: Year 2, Day 182 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18
Year 2, Day 182 post vaccination
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination
Tidsramme: Year 2, Day 28 post vaccination
Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18
Year 2, Day 28 post vaccination
HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination
Tidsramme: Year 2, Day 182 post vaccination
Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18
Year 2, Day 182 post vaccination
Number of Participants With Vaccine Failure, Year 1
Tidsramme: Year 1, Post season
Number of Participants with Vaccine Failure in Year 1 by vaccine type
Year 1, Post season
Number of Participants With Vaccine Failure, Year 2
Tidsramme: Year 2, Post season
Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
Year 2, Post season

Samarbejdspartnere og efterforskere

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

Sponsor

Marshfield Clinic Research Foundation

Samarbejdspartnere

Centers for Disease Control and Prevention

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. september 2016

Primær færdiggørelse (Faktiske)

1. april 2018

Studieafslutning (Faktiske)

1. september 2018

Datoer for studieregistrering

Først indsendt

16. august 2016

Først indsendt, der opfyldte QC-kriterier

16. august 2016

Først opslået (Skøn)

19. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MCL10416

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Immunrespons

Kliniske forsøg med High Dose Influenza vaccine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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