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

2 listopada 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

2333

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Huntsville, Alabama, Stany Zjednoczone, 35802
      • Mobile, Alabama, Stany Zjednoczone, 36608
    • Arizona
      • Chandler, Arizona, Stany Zjednoczone, 85224
      • Mesa, Arizona, Stany Zjednoczone, 85206
      • Mesa, Arizona, Stany Zjednoczone, 85213
    • Arkansas
      • Harrisburg, Arkansas, Stany Zjednoczone, 72452
      • Jonesboro, Arkansas, Stany Zjednoczone, 72401
    • California
      • Anaheim, California, Stany Zjednoczone, 92804
      • Anaheim, California, Stany Zjednoczone, 92801
      • Downey, California, Stany Zjednoczone, 90241
      • Garden Grove, California, Stany Zjednoczone, 92844
      • Modesto, California, Stany Zjednoczone, 95350
      • Paramount, California, Stany Zjednoczone, 90723
      • Sacramento, California, Stany Zjednoczone, 95816
      • San Diego, California, Stany Zjednoczone, 92103-6204
      • San Francisco, California, Stany Zjednoczone, 94102
      • Santa Rosa, California, Stany Zjednoczone, 95405
      • West Covina, California, Stany Zjednoczone, 91790
    • Colorado
      • Colorado Springs, Colorado, Stany Zjednoczone, 80907
      • Denver, Colorado, Stany Zjednoczone, 80246
      • Denver, Colorado, Stany Zjednoczone, 80249
      • Thornton, Colorado, Stany Zjednoczone, 80233
    • Florida
      • Boca Raton, Florida, Stany Zjednoczone, 33432
      • Lake Mary, Florida, Stany Zjednoczone, 32746
      • Melbourne, Florida, Stany Zjednoczone, 32935
      • Miami Beach, Florida, Stany Zjednoczone, 33141
      • Opa Locka, Florida, Stany Zjednoczone, 33055
      • Pinellas Park, Florida, Stany Zjednoczone, 33781
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30338
      • Marietta, Georgia, Stany Zjednoczone, 30062
      • Woodstock, Georgia, Stany Zjednoczone, 30189
    • Idaho
      • Boise, Idaho, Stany Zjednoczone, 83642
    • Illinois
      • Peoria, Illinois, Stany Zjednoczone, 61602
    • Indiana
      • Mishawaka, Indiana, Stany Zjednoczone, 46545
    • Iowa
      • Council Bluffs, Iowa, Stany Zjednoczone, 51503
    • Kansas
      • Newton, Kansas, Stany Zjednoczone, 67114
      • Wichita, Kansas, Stany Zjednoczone, 67207
      • Wichita, Kansas, Stany Zjednoczone, 67010
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40509
      • Louisville, Kentucky, Stany Zjednoczone, 40291
    • Louisiana
      • Metairie, Louisiana, Stany Zjednoczone, 70006
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64114
      • St. Louis, Missouri, Stany Zjednoczone, 63141
    • Nebraska
      • Bellevue, Nebraska, Stany Zjednoczone, 68005
      • Fremont, Nebraska, Stany Zjednoczone, 68025
      • Omaha, Nebraska, Stany Zjednoczone, 68114
      • Omaha, Nebraska, Stany Zjednoczone, 68134
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89104
    • New York
      • Binghamton, New York, Stany Zjednoczone, 13901
    • North Carolina
      • Wilmington, North Carolina, Stany Zjednoczone, 28401
    • Ohio
      • Akron, Ohio, Stany Zjednoczone, 44311
      • Cincinnati, Ohio, Stany Zjednoczone, 45249
      • Cleveland, Ohio, Stany Zjednoczone, 44106
      • Cleveland, Ohio, Stany Zjednoczone, 44122
      • Dayton, Ohio, Stany Zjednoczone, 45414
      • Dayton, Ohio, Stany Zjednoczone, 45406
      • Kettering, Ohio, Stany Zjednoczone, 45429
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73103
      • Tulsa, Oklahoma, Stany Zjednoczone, 74127
    • Pennsylvania
      • Erie, Pennsylvania, Stany Zjednoczone, 16505
      • Erie, Pennsylvania, Stany Zjednoczone, 16508
      • Hermitage, Pennsylvania, Stany Zjednoczone, 16148
      • Sellersville, Pennsylvania, Stany Zjednoczone, 18960
      • Upper St. Clair, Pennsylvania, Stany Zjednoczone, 15241
    • South Carolina
      • Anderson, South Carolina, Stany Zjednoczone, 29621
      • Charleston, South Carolina, Stany Zjednoczone, 29403
      • Mt. Pleasant, South Carolina, Stany Zjednoczone, 29464
    • Tennessee
      • Bristol, Tennessee, Stany Zjednoczone, 37620
      • Jefferson City, Tennessee, Stany Zjednoczone, 37760
      • Lebanon, Tennessee, Stany Zjednoczone, 37087
      • Nashville, Tennessee, Stany Zjednoczone, 37203
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78705
      • Dallas, Texas, Stany Zjednoczone, 75231
      • Fort Worth, Texas, Stany Zjednoczone, 76107
      • Fort Worth, Texas, Stany Zjednoczone, 76135
      • Round Rock, Texas, Stany Zjednoczone, 78681
      • San Angelo, Texas, Stany Zjednoczone, 76904
      • San Antonio, Texas, Stany Zjednoczone, 78229
    • Utah
      • Draper, Utah, Stany Zjednoczone, 84020
      • Layton, Utah, Stany Zjednoczone, 84041
      • Salt Lake City, Utah, Stany Zjednoczone, 84121
      • Salt Lake City, Utah, Stany Zjednoczone, 84109
      • Salt Lake City, Utah, Stany Zjednoczone, 84124
      • South Jordan, Utah, Stany Zjednoczone, 84095
      • West Jordan, Utah, Stany Zjednoczone, 84088
    • Virginia
      • Burke, Virginia, Stany Zjednoczone, 22015
      • Charlottesville, Virginia, Stany Zjednoczone, 22902

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

4 lata do 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: QIVc (≥4 to <18 years)
Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
Biologiczny: QIVc
Novartis Investigational Quadrivalent Vaccine
Aktywny 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
Biologiczny: TIV1c
Licensed Influenza Vaccine
Aktywny 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
Biologiczny: TIV2c
Novartis Investigational Vaccine

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Vaccines

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2013

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2014

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2014

Daty rejestracji na studia

Pierwszy przesłany

7 listopada 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 listopada 2013

Pierwszy wysłany (Oszacować)

25 listopada 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

8 grudnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2015

Ostatnia weryfikacja

1 listopada 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • V130_03

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Grypa

Badania kliniczne na QIVc

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Warunki medyczne

Interwencje lekowe

CROs by country

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Warunki

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Interwencje lekowe

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Lokalizacje

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