- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00530660
Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)
7. oktober 2015 opdateret af: Ology Bioservices
An Open-label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501)
The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population.
A data safety monitoring board will review the safety data after the booster vaccination.
The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
141
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Vienna, Østrig, 1090
- University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
-
-
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 46 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Subjects who participated in Study 810501 will be eligible for participation in the study if they:
- Completed the Day 42 visit in study 810501
- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
- Agree to keep a daily record of symptoms for the duration of the study
- If female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
Exclusion Criteria:
- Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
- Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
- Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
- Are unable to lead an independent life as a result of either physical or mental handicap
- Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
- Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Have undergone systemic corticoid therapy within 30 days prior to study entry
- Have a functional or surgical asplenia
- Have a known or suspected problem with alcohol or drug abuse
- Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female, are pregnant or lactating
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)
Tidsramme: 9 months
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9 months
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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
1. september 2007
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. oktober 2008
Datoer for studieregistrering
Først indsendt
14. september 2007
Først indsendt, der opfyldte QC-kriterier
14. september 2007
Først opslået (Skøn)
17. september 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. oktober 2015
Sidst verificeret
1. december 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 810703
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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