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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

29. oktober 2015 opdateret af: Novartis

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2719

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33143
        • Miami Research Associates
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County Clin-Trials
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68134
        • Meridien Clinical Research
    • New York
      • Endwell, New York, Forenede Stater, 13760
        • Regional Clinical Research
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research, Inc
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Triangle Medical Research Associates
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Triangle Medical Research Associates
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Carolina Medical Trials
    • Ohio
      • Franklin, Ohio, Forenede Stater, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • IPS Research
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16506
        • West Ridge Family Practice (adult)
      • Jefferson Hills, Pennsylvania, Forenede Stater, 15025
        • Primary Physicians Research Inc. (adult)
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Omega Clinical Research
    • Texas
      • Dallas, Texas, Forenede Stater, 75234
        • Research Across America
      • Houston, Texas, Forenede Stater, 77055
        • West Houston Clinical Research Service
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84121
        • J. Lewis Research, Inc./Foothill Family Clinic South
      • Salt Lake City, Utah, Forenede Stater, 84109
        • J.Lewis Research, Inc./Foothill Family Clinic
    • Virginia
      • Burke, Virginia, Forenede Stater, 22015
        • PI-Coor Clinical Research
      • Fairfax, Virginia, Forenede Stater, 22030
        • PI Coor Clinical Research
      • Richmond, Virginia, Forenede Stater, 23219
        • Virginia Commonwealth University
  • Mexico
      • Tlalpan, Mexico, 14000
        • Instituto Nacional de Ciencias

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:

  • Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

  • History of serious disease.
  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
  • Known or suspected impairment/alteration of immune function.
  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
  • Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
  • For additional entry criteria, please refer to protocol.

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: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eksperimentel: 30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
Biologisk: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Tidsramme: 21 days after each vaccination
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Tidsramme: 21 days after each vaccination
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Tidsramme: 21 days after each vaccination
Geometric mean hemagglutinin inhibition (HI) titer = GMT
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Tidsramme: 21 days after each vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Tidsramme: 21 days after each vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Tidsramme: 21 days after vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Tidsramme: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Tidsramme: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Tidsramme: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Tidsramme: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis

Samarbejdspartnere

Novartis Vaccines

Efterforskere

  • Studieleder: Novartis Vaccine and Diagnostics, Novartis

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 2009

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

2. september 2009

Først indsendt, der opfyldte QC-kriterier

7. september 2009

Først opslået (Skøn)

9. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V112_01

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Kliniske forsøg med Influenza

Kliniske forsøg med MF59-eH1N1_f

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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