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A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

20 września 2015 zaktualizowane przez: Seqirus

A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

402

Faza

  • Faza 4

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90036
        • Site 286
    • Idaho
      • Boise, Idaho, Stany Zjednoczone, 83642
        • Site 289
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63141
        • Site 287
    • New York
      • Binghamton, New York, Stany Zjednoczone, 13901
        • Site 285
    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27704
        • Site 290
      • Raleigh, North Carolina, Stany Zjednoczone, 27609
        • Site 281
      • Winston-Salem, North Carolina, Stany Zjednoczone, 27103
        • Site 280
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29403
        • Site 284
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78705
        • Site 283
      • Fort Worth, Texas, Stany Zjednoczone, 76135
        • Site 282
      • San Angelo, Texas, Stany Zjednoczone, 76904
        • Site 288

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

5 lat do 8 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Males or females aged 5 to less than 9 years at the time of first study vaccination.
  • The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
  • In good health, as determined by medical history and a targeted physical examination (if warranted).

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
  • Clinical signs of significant active infection or an elevated oral temperature at study entry.
  • A clinically significant medical or psychiatric condition.
  • A history of seizures or febrile convulsions or Guillain-Barré syndrome.
  • Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
  • Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
  • Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
  • Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
  • Currently receiving treatment with warfarin or other anticoagulants.

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: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
Biologiczny: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Aktywny komparator: Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Biologiczny: Comparator Quadrivalent Influenza Virus Vaccine
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Inne nazwy:
  • Czterowartościowy Fluzone

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
7 days after each administration of vaccine.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
7 days after each administration of vaccine.
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).
7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
7 days after each administration of vaccine.
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.
7 days after each administration of vaccine.
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Ramy czasowe: 7 days after each administration of vaccine.
The number of subjects experiencing at least one SAE.
7 days after each administration of vaccine.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Seqirus

Śledczy

  • Dyrektor Studium: bioCSL Pty Ltd Clinical Program Director, Seqirus

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 września 2014

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

6 sierpnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 sierpnia 2014

Pierwszy wysłany (Oszacować)

8 sierpnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

16 października 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2015

Ostatnia weryfikacja

1 września 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CSLCT-USF-10-69
  • 2015-000175-27 (Numer EudraCT)

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 .

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