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Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

2. november 2015 opdateret af: Novartis Vaccines

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2333

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
      • Mobile, Alabama, Forenede Stater, 36608
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
      • Mesa, Arizona, Forenede Stater, 85206
      • Mesa, Arizona, Forenede Stater, 85213
    • Arkansas
      • Harrisburg, Arkansas, Forenede Stater, 72452
      • Jonesboro, Arkansas, Forenede Stater, 72401
    • California
      • Anaheim, California, Forenede Stater, 92804
      • Anaheim, California, Forenede Stater, 92801
      • Downey, California, Forenede Stater, 90241
      • Garden Grove, California, Forenede Stater, 92844
      • Modesto, California, Forenede Stater, 95350
      • Paramount, California, Forenede Stater, 90723
      • Sacramento, California, Forenede Stater, 95816
      • San Diego, California, Forenede Stater, 92103-6204
      • San Francisco, California, Forenede Stater, 94102
      • Santa Rosa, California, Forenede Stater, 95405
      • West Covina, California, Forenede Stater, 91790
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
      • Denver, Colorado, Forenede Stater, 80246
      • Denver, Colorado, Forenede Stater, 80249
      • Thornton, Colorado, Forenede Stater, 80233
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33432
      • Lake Mary, Florida, Forenede Stater, 32746
      • Melbourne, Florida, Forenede Stater, 32935
      • Miami Beach, Florida, Forenede Stater, 33141
      • Opa Locka, Florida, Forenede Stater, 33055
      • Pinellas Park, Florida, Forenede Stater, 33781
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30338
      • Marietta, Georgia, Forenede Stater, 30062
      • Woodstock, Georgia, Forenede Stater, 30189
    • Idaho
      • Boise, Idaho, Forenede Stater, 83642
    • 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, 67010
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
      • Louisville, Kentucky, Forenede Stater, 40291
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64114
      • St. Louis, Missouri, Forenede Stater, 63141
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater, 68005
      • Fremont, Nebraska, Forenede Stater, 68025
      • Omaha, Nebraska, Forenede Stater, 68114
      • Omaha, Nebraska, Forenede Stater, 68134
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
    • New York
      • Binghamton, New York, Forenede Stater, 13901
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28401
    • Ohio
      • Akron, Ohio, Forenede Stater, 44311
      • Cincinnati, Ohio, Forenede Stater, 45249
      • Cleveland, Ohio, Forenede Stater, 44106
      • Cleveland, Ohio, Forenede Stater, 44122
      • Dayton, Ohio, Forenede Stater, 45414
      • Dayton, Ohio, Forenede Stater, 45406
      • Kettering, Ohio, Forenede Stater, 45429
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
      • Tulsa, Oklahoma, Forenede Stater, 74127
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16505
      • Erie, Pennsylvania, Forenede Stater, 16508
      • Hermitage, Pennsylvania, Forenede Stater, 16148
      • Sellersville, Pennsylvania, Forenede Stater, 18960
      • Upper St. Clair, Pennsylvania, Forenede Stater, 15241
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
      • Charleston, South Carolina, Forenede Stater, 29403
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
      • Jefferson City, Tennessee, Forenede Stater, 37760
      • Lebanon, Tennessee, Forenede Stater, 37087
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Austin, Texas, Forenede Stater, 78705
      • Dallas, Texas, Forenede Stater, 75231
      • Fort Worth, Texas, Forenede Stater, 76107
      • Fort Worth, Texas, Forenede Stater, 76135
      • Round Rock, Texas, Forenede Stater, 78681
      • San Angelo, Texas, Forenede Stater, 76904
      • San Antonio, Texas, Forenede Stater, 78229
    • Utah
      • Draper, Utah, Forenede Stater, 84020
      • Layton, Utah, Forenede Stater, 84041
      • 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
      • West Jordan, Utah, Forenede Stater, 84088
    • Virginia
      • Burke, Virginia, Forenede Stater, 22015
      • Charlottesville, Virginia, Forenede Stater, 22902

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

4 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female aged 4 years to less than 18 years of age.
  2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
  3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.

Exclusion Criteria:

  1. Individuals recently vaccinated against influenza
  2. Subjects with contraindications to receive 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: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: QIVc (≥4 to <18 years)
Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
Biologisk: QIVc
Novartis Investigational Quadrivalent Vaccine
Aktiv komparator: TIV1c (≥4 to <18 years)
Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season
Biologisk: TIV1c
Licensed Influenza Vaccine
Aktiv komparator: TIV2c (≥4 to <18 years)
Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014
Biologisk: TIV2c
Novartis Investigational Vaccine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Tidsramme: Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or 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.
Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population 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%
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Tidsramme: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.

The CBER criterion for adult population was 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%
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Tidsramme: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain
Tidsramme: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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 did not exceed the superiority margin of 1
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.

Superiority criterion 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 does not exceed the margin of 0 points
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain
Tidsramme: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c
Tidsramme: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last 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 does not exceed the margin of 0 points
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata
Tidsramme: Day 1 to 7 after last vaccination
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.
Day 1 to 7 after last vaccination
Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group
Tidsramme: Day 1 to 210 post vaccination
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), 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 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.
Day 1 to 210 post vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Vaccines

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. november 2013

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 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)

8. 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_03

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 Influenza

Kliniske forsøg med QIVc

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Qatar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner