- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00921973
Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults
22. september 2014 oppdatert av: VaxInnate Corporation
A Multicenter, Double-Blinded, Randomized, Placebo Controlled Study to Investigate the Safety and Immunogenicity of VAX102 When Given in the Same Arm With the Standard Influenza Vaccine in Healthy Adults
The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years.
The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kansas
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Lenexa, Kansas, Forente stater, 66219
- Johnson County Clin Trials
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Tennessee
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Nashville, Tennessee, Forente stater, 37212
- Vanderbilt Clinical Trials Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 49 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female aged 18 - 49 years inclusive
- Give written informed consent to participate in the study and adherence to all protocol requirements.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
- Females willing to practice birth control during the study.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Did not receive influenza vaccination (TIV) during the 2008-2009 influenza season.
Exclusion Criteria:
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
- History of cancer.
- History of impaired immunoresponsiveness, including diabetes.
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs or any components of the study vaccines.
- Received influenza vaccination during the 2008-2009 season
- History of systemic hypersensitivity reactions to egg proteins, or any other component of FLUVIRIN®, or life-threatening reactions to previous influenza vaccinations.
- Has known history of Guillain-Barré Syndrome
- Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed.
- Participated in a clinical trial or received or planned administration of an investigational compound within 30 days before receiving study vaccine and/or during the study through the Day 28 evaluation.
- Was vaccinated with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the study vaccine.
- History of anaphylactic type reaction to injected vaccines.
- History of drug or chemical abuse in the year before the study.
- Use of new prescription medications started within 7 days before study entry.
- Receipt of any blood products, including immunoglobulin, within 6 months before administration of study vaccine or anticipated receipt during the study period.
- Donation of blood or blood products within 8 weeks before study entry or at any time during the study.
- Has clinical signs of active infection and/or oral temperature of ≥ 38 (100.4 ºF). Study entry may be deferred for such individuals at the discretion of the investigator.
- Has evidence or history of (within the previous 12 months) drug or alcohol abuse.
- Any condition that, in the opinion of the investigator, might interfere with study objectives.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
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All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
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Aktiv komparator: VAX102
Simultaneous administration of VAX102 1 ug i.m. plus TIV
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All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Immune response
Tidsramme: 2 months
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2 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2009
Primær fullføring (Faktiske)
1. juli 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
15. juni 2009
Først innsendt som oppfylte QC-kriteriene
16. juni 2009
Først lagt ut (Anslag)
17. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. september 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VAX102-07
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på VAX102
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VaxInnate CorporationFullført
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VaxInnate CorporationBill and Melinda Gates FoundationFullførtInfluensainfeksjonForente stater