Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
19 stycznia 2016 zaktualizowane przez: Novartis Vaccines
A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1398
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Balve, Niemcy
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Duisberg, Niemcy
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Garmisch-Partenkirchen, Niemcy
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Hannover, Niemcy
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Herborn, Niemcy
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Illingen, Niemcy
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Kiel, Niemcy
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Laufach, Niemcy
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Marburg, Niemcy
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Midlum, Niemcy
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Olpe, Niemcy
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Potsdam, Niemcy
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Regensburg, Niemcy
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Unterschleißheim, Niemcy
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Wiesbaden, Niemcy
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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
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
- Able to comply with all study procedures and requirements.
Exclusion Criteria:
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
- Fatal prognosis of an underlying medical condition (<12 months life expectancy);
- History of Guillain-Barre syndrome;
- Bleeding diathesis or receiving anticoagulants of the coumarin type;
- Hospitalization or residence in a nursing care facility;
- Planned to receive seasonal influenza vaccine outside of this study;
- Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
- Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
- Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;
- Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
- Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
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: Zadanie dla jednej grupy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: cTIV
Subjects received one vaccination of cell culture-derived influenza vaccine
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1 dose of 0.5 mL in the deltoid region of the non-dominant arm
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Aktywny komparator: TIV
Subjects received one vaccination of egg-derived influenza vaccine
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1 dose of 0.5 mL in the deltoid region of the non-dominant arm
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
Ramy czasowe: From Day 1 up to and including Day 7 post-vaccination
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Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.
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From Day 1 up to and including Day 7 post-vaccination
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
Ramy czasowe: From Day 1 through Day 7 post-vaccination
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Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).
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From Day 1 through Day 7 post-vaccination
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Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
Ramy czasowe: From Day 1 through Day 7 post-vaccination
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Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.
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From Day 1 through Day 7 post-vaccination
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Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
Ramy czasowe: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
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Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay.
This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).
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Before vaccination (Day 1) and three weeks after vaccination (Day 22)
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Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
Ramy czasowe: Three weeks post-vaccination (Day 22)
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Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer.
According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).
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Three weeks post-vaccination (Day 22)
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Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Ramy czasowe: Before vaccination (Day 1) and three weeks after vaccination (Day 22)
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Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).
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Before vaccination (Day 1) and three weeks after vaccination (Day 22)
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Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Ramy czasowe: Three weeks post-vaccination (Day 22)
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Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV.
CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).
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Three weeks post-vaccination (Day 22)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
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 2007
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2008
Ukończenie studiów (Rzeczywisty)
1 lipca 2008
Daty rejestracji na studia
Pierwszy przesłany
16 listopada 2007
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 listopada 2007
Pierwszy wysłany (Oszacować)
19 listopada 2007
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
17 lutego 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 stycznia 2016
Ostatnia weryfikacja
1 stycznia 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- V58P14
- 2007-002872-32
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