- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01596725
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
5. februar 2014 opdateret af: Novavax
A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 2.
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults.
The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21.
There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Biologisk: Monovalent Avian Influenza VLP (H5N1)
- Biologisk: Monovalent Avian Influenza VLP (H5N1)
- Biologisk: Monovalent Avian Influenza VLP (H5N1); Adjuvant
- Biologisk: Monovalent Avian Influenza VLP (H5N1); Adjuvant
- Biologisk: Monovalent Avian Influenza VLP (H5N1); Adjuvant
- Biologisk: Saline Placebo
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
333
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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California
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Anaheim, California, Forenede Stater, 92801
- Anaheim Clinical Trials
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Florida
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Miami, Florida, Forenede Stater, 33143
- Miami Research Associates
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Pembroke Pines, Florida, Forenede Stater, 33026
- Broward Research Group
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- Johnson County Clin-Trials
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- Clinical Trials of Texas
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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 49 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adult male or female, ≥18 and ≤49 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- All women must have a negative urine pregnancy test prior to each vaccination. Women will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD).
Exclusion Criteria:
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. Asymptomatic conditions (e.g., hypertension, dyslipidemia) that are being managed medically and that are not associated with evidence of end-organ damage are not exclusionary provided they are clinically stable (defined as no unscheduled medical interventions or change in medications for cause within 3 months).
- Any history of jaundice, or of hepatic injury due to drug (prescription, OTC, or illicit) or alcohol use or viral hepatitis; or the presence of hepatitis B surface antigen or hepatitis C antibody at screening.
- Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in serum glutamic-pyruvic transaminase/alanine aminotransferase (SGPT/ALT), serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST), alkaline phosphatase, or total bilirubin levels.
- Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 3 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- History of a serious reaction to prior influenza vaccination.
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- Received any vaccine in the 4 weeks preceding the study vaccination; or any A/H5N1 avian influenza vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, including HIV infection, as determined by history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation.
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
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: Gruppe A
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Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
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Eksperimentel: Gruppe B
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Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
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Eksperimentel: Gruppe C
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Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
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Eksperimentel: Gruppe D
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Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
|
Eksperimentel: Gruppe E
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Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
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Eksperimentel: Gruppe F
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Placebo; intramuscular, deltoid, Day 0 and Day 21
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 2.
Tidsramme: Day 42
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Day 42
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 2.
Tidsramme: Day 42
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Day 42
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Nigel Thomas, Ph.D, Novavax
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.
Hjælpsomme links
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. maj 2012
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
9. maj 2012
Først indsendt, der opfyldte QC-kriterier
10. maj 2012
Først opslået (Skøn)
11. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NVX778.P102
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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