- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01659086
Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
14. června 2018 aktualizováno: GlaxoSmithKline
An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
422
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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Quebec
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Sherbrooke, Quebec, Kanada, J1H 2G2
- GSK Investigational Site
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Florida
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Miami, Florida, Spojené státy, 33143
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, Spojené státy, 08817
- GSK Investigational Site
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Texas
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Austin, Texas, Spojené státy, 78705
- 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 64 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Male or female adults from 18 to 64 years of age (inclusive) at time of first study vaccination.
- Written informed consent obtained from the subject.
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Healthy subjects as established by medical history and physical examination.
- Body weight of at least 110 lbs (49.9 kg).
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if they have practiced adequate contraception for 30 days prior to vaccination, and have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after booster dose administration.
Exclusion Criteria:
- Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence or evidence of substance abuse.
Diagnosed with cancer, or treatment for cancer within three years.
- Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis may enroll.
- Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection (no laboratory testing required).
- Receipt of systemic glucocorticoids (e.g., prednisone ≥ 10 mg/day for more than 14 consecutive days) within 30 days prior to the first dose of study vaccine, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 365 days of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
- Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/product.
- Planned administration of any vaccine other than the study vaccine/product before blood sampling at the Day 42 visit.
- Previous administration of any H9 vaccine or physician-confirmed H9 disease.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Receipt of any immunoglobulins and/or any blood products within 90 days before study enrolment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first vaccination.
- Lactating or nursing women.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
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: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Group A
Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group B
Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group C
Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group D
Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group E
Subjects will receive the investigational vaccine GSK2654909A and placebo
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1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5).
All doses to be administered IM in deltoid region of arm.
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Experimentální: Group F
Subjects will receive the investigational vaccine GSK2654911A formulation 5
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group G
Subjects will receive the investigational vaccine GSK2654911A formulation 6
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group H
Subjects will receive the investigational vaccine GSK2654911A formulation 7
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group I
Subjects will receive the investigational vaccine GSK2654911A formulation 8
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2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group.
All doses to be administered intramuscularly (IM) in deltoid region of arm.
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Experimentální: Group J
Subjects will receive the investigational vaccine GSK2654909A
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2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5).
All doses to be administered IM in deltoid region of arm.
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Komparátor placeba: Placebo Group
Subjects will receive Placebo
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1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Časové okno: Day 21
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Day 21
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Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Časové okno: Day 42
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Day 42
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Humoral immune response in terms of HI antibodies against H9N2 antigen
Časové okno: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)
Časové okno: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen
Časové okno: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
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Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)
Časové okno: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
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GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
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Occurrence of local and general symptoms
Časové okno: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
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During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
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Occurrence and relationship to vaccination of unsolicited adverse events
Časové okno: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
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Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
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Occurrence and relationship to vaccination of adverse events with medically attended visits
Časové okno: During the entire study period (Day 0 - Day 546)
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During the entire study period (Day 0 - Day 546)
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Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome
Časové okno: During the entire study period (Day 0 - Day 546)
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During the entire study period (Day 0 - Day 546)
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Number of subjects with clinical safety laboratory abnormalities
Časové okno: Days 0, 7, 21, 28, 42, 182, 191, and 385.
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Days 0, 7, 21, 28, 42, 182, 191, and 385.
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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 (Aktuální)
22. srpna 2012
Primární dokončení (Aktuální)
26. října 2012
Dokončení studie (Aktuální)
19. března 2014
Termíny zápisu do studia
První předloženo
3. srpna 2012
První předloženo, které splnilo kritéria kontroly kvality
6. srpna 2012
První zveřejněno (Odhad)
7. srpna 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 116358
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Časový rámec sdílení IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Kritéria přístupu pro sdílení IPD
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
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 .