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Open-Label Influenza Vaccine Evaluation (OLIVE)

3 december 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

179

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Wisconsin
      • Marshfield, Wisconsin, Förenta staterna, 54449
        • Marshfield Clinic - Marshfield Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 74 år (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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
Andra namn:
  • Fluzon 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
Andra namn:
  • 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
Andra namn:
  • Fluzon HD
Biologisk: Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Andra namn:
  • 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
Andra namn:
  • FluAd
Biologisk: Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
Andra namn:
  • 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
Andra namn:
  • Fluvirin Standard Dose
Biologisk: Recombinant Influenza vaccine
Licensed and FDA approved FluBlok vaccine to be administered to study participants
Andra namn:
  • FluBlok

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Year 2, Post season
Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history
Year 2, Post season

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Marshfield Clinic Research Foundation

Samarbetspartners

Centers for Disease Control and Prevention

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2016

Primärt slutförande (Faktisk)

1 april 2018

Avslutad studie (Faktisk)

1 september 2018

Studieregistreringsdatum

Först inskickad

16 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2016

Första postat (Uppskatta)

19 augusti 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 december 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 december 2019

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MCL10416

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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