Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
9. května 2018 aktualizováno: GlaxoSmithKline
Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
720
Fáze
- Fáze 2
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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Saku, Estonsko, 75501
- GSK Investigational Site
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Tallinn, Estonsko, 13419
- GSK Investigational Site
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Tartu, Estonsko, 50417
- 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
65 let a starší (Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria:
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
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: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Experimentální: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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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 Titer Against the Three Vaccine Strains
Časové okno: Days 0 and 21
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Titers were expressed as Geometric Mean Titers (GMTs).
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Časové okno: Days 0 and 21
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A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Časové okno: Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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HI Antibody Seroconversion Factors
Časové okno: Day 21
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Časové okno: Days 0 and 21
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A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
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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 period after vaccination
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Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Any: any symptom regardless of intensity grade.
Grade 3 pain: considerable pain at rest, which prevented normal everyday activities.
Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
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During a 7-day period after vaccination
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Duration of Solicited Local Symptoms
Časové okno: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Časové okno: During a 7-day period after vaccination
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Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C).
Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C.
Related: symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day period after vaccination
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Duration of Solicited General Symptoms
Časové okno: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Časové okno: During a 21-day 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.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Časové okno: During a 21-day period after vaccination
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Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
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During a 21-day 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 (up to Day 21)
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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.
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During the entire study period (up to Day 21)
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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
3. března 2008
Primární dokončení (Aktuální)
11. dubna 2008
Dokončení studie (Aktuální)
11. dubna 2008
Termíny zápisu do studia
První předloženo
29. února 2008
První předloženo, které splnilo kritéria kontroly kvality
10. března 2008
První zveřejněno (Odhad)
11. března 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. listopadu 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 111454
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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Plán statistické analýzy
Identifikátor informace: 111454Komentáře 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: 111454Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář informovaného souhlasu
Identifikátor informace: 111454Komentáře 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: 111454Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Zpráva o klinické studii
Identifikátor informace: 111454Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
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Protokol studie
Identifikátor informace: 111454Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulář komentované zprávy o případu
Identifikátor informace: 111454Komentáře 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 .