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Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

2. november 2015 opdateret af: Novartis Vaccines

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2680

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35802
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85050
    • California
      • Anaheim, California, Forenede Stater, 92801
      • San Diego, California, Forenede Stater, 92108
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
      • Hollywood, Florida, Forenede Stater, 33024
      • Melbourne, Florida, Forenede Stater, 32935
      • South Miami, Florida, Forenede Stater, 33143
      • West Palm Beach, Florida, Forenede Stater, 33409
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61602
    • Indiana
      • Mishawaka, Indiana, Forenede Stater, 46545
    • Iowa
      • Council Bluffs, Iowa, Forenede Stater, 51503
    • Kansas
      • Newton, Kansas, Forenede Stater, 67114
      • Wichita, Kansas, Forenede Stater, 67207
      • Wichita, Kansas, Forenede Stater, 67205
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater, 68005
      • Omaha, Nebraska, Forenede Stater, 68134
    • New York
      • Endwell, New York, Forenede Stater, 13760
      • Rochester, New York, Forenede Stater, 14609
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
      • Charlotte, North Carolina, Forenede Stater, 28209
      • Raleigh, North Carolina, Forenede Stater, 27609
      • Wilmington, North Carolina, Forenede Stater, 28401
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
    • South Dakota
      • Dakota Dunes, South Dakota, Forenede Stater, 57049
    • Texas
      • Austin, Texas, Forenede Stater, 78705
      • Austin, Texas, Forenede Stater, 78745
      • Dallas, Texas, Forenede Stater, 75231
      • Fort Worth, Texas, Forenede Stater, 76135
      • San Angelo, Texas, Forenede Stater, 76904
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84121
      • Salt Lake City, Utah, Forenede Stater, 84109
      • Salt Lake City, Utah, Forenede Stater, 84124
      • South Jordan, Utah, Forenede Stater, 84095

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:

  1. Male or female ages 18 years and older.
  2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.

Exclusion Criteria:

  1. Individuals recently vaccinated against influenza
  2. Subjects with contraindications to receive influenza vaccine
  3. Please contact the site for additional eligibility criteria

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
Eksperimentel: QIVc
Influenza vaccine
Biologisk: QIVc
Novartis Investigational Quadrivalent Vaccine
Aktiv komparator: TIV1c
Influenza vaccine
Biologisk: TIV1c
Licensed Influenza Vaccine
Aktiv komparator: TIV2c
Influenza vaccine
Biologisk: TIV2c
Novartis Investigational Vaccine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Tidsramme: Three weeks post vaccination (Day 22)

Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.

Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Three weeks post vaccination (Day 22)
2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer
Three weeks post vaccination (Day 22)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%
Three weeks post vaccination (Day 22)
4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%
Three weeks post vaccination (Day 22)
5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0
Three weeks post vaccination (Day 22)
6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%
Three weeks post vaccination (Day 22)
7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%
Three weeks post vaccination (Day 22)
8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
Tidsramme: Three weeks post vaccination (Day 22)

Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.

Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.
Three weeks post vaccination (Day 22)
9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Three weeks post vaccination (Day 22)
10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
Tidsramme: Three weeks post vaccination (Day 22)

Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.

Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1
Three weeks post vaccination (Day 22)
11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
Tidsramme: Three weeks post vaccination (Day 22)
Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points
Three weeks post vaccination (Day 22)
12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Tidsramme: Day 1 to 7 post vaccination
Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Day 1 to 7 post vaccination
13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
Tidsramme: Day 1 to 181 post vaccination
Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)
Day 1 to 181 post vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Vaccines

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. november 2013

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

7. november 2013

Først indsendt, der opfyldte QC-kriterier

18. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V130_01

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Kliniske forsøg med Influenza

Kliniske forsøg med QIVc

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Betingelser

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