- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00714285
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
9. května 2018 aktualizováno: GlaxoSmithKline
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
420
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Hradec Kralove, Česko, 500 03
- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 60 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Experimentální: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Aktivní komparátor: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Aktivní komparátor: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Časové okno: At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
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At Day 0 and Day 21
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Časové okno: At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Day 21
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HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Časové okno: Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Časové okno: At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Časové okno: During a 7 day (Days 0-6) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as considerable pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
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During a 7 day (Days 0-6) follow-up period after vaccination
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Časové okno: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Časové okno: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature ≥39.0°C.
Related = symptoms considered by the investigator to have a causal relationship to vaccination
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Časové okno: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 37.5 °C.
Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature above 39.0°C. .
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Časové okno: During the entire study period (Days 0-180)
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MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
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During the entire study period (Days 0-180)
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Časové okno: During a 21 day (Days 0-20) follow-up period after vaccination-
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Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
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During a 21 day (Days 0-20) follow-up period after vaccination-
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Časové okno: During the entire study period (Days 0-180)
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (Days 0-180)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
14. července 2008
Primární dokončení (Aktuální)
28. ledna 2009
Dokončení studie (Aktuální)
28. ledna 2009
Termíny zápisu do studia
První předloženo
11. července 2008
První předloženo, které splnilo kritéria kontroly kvality
11. července 2008
První zveřejněno (Odhad)
14. července 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. června 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. května 2018
Naposledy ověřeno
1. března 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 111295
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studijní data/dokumenty
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Formulář informovaného souhlasu
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Zpráva o klinické studii
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Formulář komentované zprávy o případu
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Soubor dat jednotlivých účastníků
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Specifikace datové sady
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Plán statistické analýzy
Identifikátor informace: 111295Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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