- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01459276
A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects
18. maj 2012 opdateret af: Fluart Innovative Vaccine Ltd, Hungary
A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6μgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects
The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1206
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Budapest, Ungarn, 1083
- Family Doctor's Office
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Budapest, Ungarn, 1136
- Family Doctor's Office
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Pilisvörösvár, Ungarn, 2085
- Family Doctor's Office
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Pest
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Biatorbágy, Pest, Ungarn, 2051
- Péter Vajer
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Hatvan, Pest, Ungarn, 3000
- Barna Bőze
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Szentendre, Pest, Ungarn, 2000
- Family Doctor's Office
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Vecsés, Pest, Ungarn, 2220
- Tibor Hrutka
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- male and female adult volunteers aged 18 years or older,
- mentally competent,
- able to understand and comply with all study requirements,
- willing and able to give written informed consent prior to initiation of study procedures,
- in good health (as determined by clinical judgement of the investigator on the basis of medical history and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known, adequately treated, clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
- Female subjects aged 18 to 60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
- Absence of existence of any exclusion criteria.
Exclusion Criteria:
- Pregnancy, breast-feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
- History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
- History of Guillain-Barré syndrome;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
- Immunosuppressive therapy within the past 36 months;
- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants;
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;
- Suspected or known HIV, HBV or HCV infection;
- Acute disease and/or axillary temperature ≥37oC within the past 3 days;
- Vaccine therapy within the past 4 weeks;
- Influenza vaccination (any kind) within the past 6 months;
- Experimental drug therapy within the past 4 weeks;
- Concomitant participation in another clinical study;
- Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
- Past or current psychiatric disease of the subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
- Alcohol or drug abuse of the subject.
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: FAB-6011
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens
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Én 0,5 ml injektion af FAB-6011 trivalent influenzavaccine indeholdende 6μgHA sæsonbestemte A/H1N1-, A/H3N2- og B-influenzaantigener.
Andre navne:
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Aktiv komparator: FLUVALAB
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens
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Én 0,5 ml injektion af FLUVAL AB trivalent influenzavaccine indeholdende 15μgHA sæsonbestemte A/H1N1-, A/H3N2- og B-influenzaantigener.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Measures of immunogenicity
Tidsramme: 21-28 days following vaccination
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The measures of immunogenicity (by using HI test) are:
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21-28 days following vaccination
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Measures of safety
Tidsramme: 21-28 days following vaccination
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The measures of safety are: Number and percentage of subjects with at least
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21-28 days following vaccination
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measures of long term immunogenicity
Tidsramme: 110-120 days following vaccination
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The measures of long term immunogenicity (by using HI test) are:
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110-120 days following vaccination
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Measures of long term safety
Tidsramme: 110-120 days following vaccination
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The measures of long term safety are: Number and percentage of subjects with at least
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110-120 days following vaccination
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Gabor Kollar, MD, Omninvest Ltd
- Ledende efterforsker: Ágnes Hasitz, MD, Family Doctor's Office, Szentendre
- Ledende efterforsker: Judit Simon, MD, Family Doctor's Office, Budapest
- Ledende efterforsker: Péter Torzsa, MD, Family Doctor's Office, Budapest
- Ledende efterforsker: Ferenc Tamás, MD, Family Doctor's Office, Pilisvörösvár
- Ledende efterforsker: Barna Bőze, MD, Family Doctor's Office, Hatvan
- Ledende efterforsker: Tibor Hrutka, MD, Family Doctor's Office, Vecsés
- Ledende efterforsker: Péter Vajer, MD, Family Doctor's Office, Biatorbágy
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
1. oktober 2011
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. marts 2012
Datoer for studieregistrering
Først indsendt
19. oktober 2011
Først indsendt, der opfyldte QC-kriterier
21. oktober 2011
Først opslået (Skøn)
25. oktober 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FluvalAB-H-15
- 2011-003314-16 (EudraCT nummer)
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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Kliniske forsøg med Vaccination med FAB-6011
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Fluart Innovative Vaccine Ltd, HungaryAfsluttet