- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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. juni 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
422
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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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, Forenede Stater, 33143
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, Forenede Stater, 08817
- GSK Investigational Site
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Texas
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Austin, Texas, Forenede Stater, 78705
- GSK Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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.
|
Eksperimentel: 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.
|
Eksperimentel: Group D
Subjects will receive the investigational vaccine GSK2654911A formulation 4 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.
|
Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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.
|
Eksperimentel: Group I
Subjects will receive the investigational vaccine GSK2654911A formulation 8
|
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.
|
Eksperimentel: Group J
Subjects will receive the investigational vaccine GSK2654909A
|
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.
|
Placebo komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Tidsramme: 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
Tidsramme: Day 42
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Day 42
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Humoral immune response in terms of HI antibodies against H9N2 antigen
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. august 2012
Primær færdiggørelse (Faktiske)
26. oktober 2012
Studieafslutning (Faktiske)
19. marts 2014
Datoer for studieregistrering
Først indsendt
3. august 2012
Først indsendt, der opfyldte QC-kriterier
6. august 2012
Først opslået (Skøn)
7. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116358
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD for this study will be made available via the Clinical Study Data Request site.
IPD-delingstidsramme
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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