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

2 listopada 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

2680

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
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85050
    • California
      • Anaheim, California, Stany Zjednoczone, 92801
      • San Diego, California, Stany Zjednoczone, 92108
    • Florida
      • Coral Gables, Florida, Stany Zjednoczone, 33134
      • Hollywood, Florida, Stany Zjednoczone, 33024
      • Melbourne, Florida, Stany Zjednoczone, 32935
      • South Miami, Florida, Stany Zjednoczone, 33143
      • West Palm Beach, Florida, Stany Zjednoczone, 33409
    • 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, 67205
    • Louisiana
      • Metairie, Louisiana, Stany Zjednoczone, 70006
    • Maryland
      • Rockville, Maryland, Stany Zjednoczone, 20850
    • Minnesota
      • Edina, Minnesota, Stany Zjednoczone, 55435
    • Nebraska
      • Bellevue, Nebraska, Stany Zjednoczone, 68005
      • Omaha, Nebraska, Stany Zjednoczone, 68134
    • New York
      • Endwell, New York, Stany Zjednoczone, 13760
      • Rochester, New York, Stany Zjednoczone, 14609
    • North Carolina
      • Cary, North Carolina, Stany Zjednoczone, 27518
      • Charlotte, North Carolina, Stany Zjednoczone, 28209
      • Raleigh, North Carolina, Stany Zjednoczone, 27609
      • Wilmington, North Carolina, Stany Zjednoczone, 28401
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
    • Rhode Island
      • Warwick, Rhode Island, Stany Zjednoczone, 02886
    • South Carolina
      • Anderson, South Carolina, Stany Zjednoczone, 29621
      • Mt. Pleasant, South Carolina, Stany Zjednoczone, 29464
    • South Dakota
      • Dakota Dunes, South Dakota, Stany Zjednoczone, 57049
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78705
      • Austin, Texas, Stany Zjednoczone, 78745
      • Dallas, Texas, Stany Zjednoczone, 75231
      • Fort Worth, Texas, Stany Zjednoczone, 76135
      • San Angelo, Texas, Stany Zjednoczone, 76904
    • Utah
      • 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

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

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

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: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: QIVc
Influenza vaccine
Biologiczny: QIVc
Novartis Investigational Quadrivalent Vaccine
Aktywny komparator: TIV1c
Influenza vaccine
Biologiczny: TIV1c
Licensed Influenza Vaccine
Aktywny komparator: TIV2c
Influenza vaccine
Biologiczny: TIV2c
Novartis Investigational Vaccine

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Vaccines

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 lipca 2014

Ukończenie studiów (Rzeczywisty)

1 lipca 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)

10 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_01

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

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