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- Sperimentazione clinica 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 giugno 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
422
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Quebec
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Sherbrooke, Quebec, Canada, J1H 2G2
- GSK Investigational Site
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Florida
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Miami, Florida, Stati Uniti, 33143
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, Stati Uniti, 08817
- GSK Investigational Site
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Texas
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Austin, Texas, Stati Uniti, 78705
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Sperimentale: Group C
Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo
|
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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Lasso di tempo: 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
Lasso di tempo: Day 42
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Day 42
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Humoral immune response in terms of HI antibodies against H9N2 antigen
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 agosto 2012
Completamento primario (Effettivo)
26 ottobre 2012
Completamento dello studio (Effettivo)
19 marzo 2014
Date di iscrizione allo studio
Primo inviato
3 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
6 agosto 2012
Primo Inserito (Stima)
7 agosto 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 giugno 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 116358
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Periodo di condivisione IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .