- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01596725
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
5 februari 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
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
Studietyp
Interventionell
Inskrivning (Faktisk)
333
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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Anaheim, California, Förenta staterna, 92801
- Anaheim Clinical Trials
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Florida
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Miami, Florida, Förenta staterna, 33143
- Miami Research Associates
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Pembroke Pines, Florida, Förenta staterna, 33026
- Broward Research Group
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Kansas
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Lenexa, Kansas, Förenta staterna, 66219
- Johnson County Clin-Trials
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 49 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Grupp A
|
Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
|
Experimentell: Grupp B
|
Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
|
Experimentell: Grupp C
|
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
|
Experimentell: Grupp D
|
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
|
Experimentell: Grupp E
|
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
|
Experimentell: Grupp F
|
Placebo; intramuscular, deltoid, Day 0 and Day 21
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 2.
Tidsram: Day 42
|
Day 42
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 2.
Tidsram: Day 42
|
Day 42
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Nigel Thomas, Ph.D, Novavax
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2012
Primärt slutförande (Faktisk)
1 augusti 2012
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
9 maj 2012
Först inskickad som uppfyllde QC-kriterierna
10 maj 2012
Första postat (Uppskatta)
11 maj 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 februari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 februari 2014
Senast verifierad
1 februari 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NVX778.P102
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Monovalent Avian Influenza VLP (H5N1)
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NovavaxDepartment of Health and Human ServicesAvslutadInfluensa (pandemi)Förenta staterna
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NovavaxAvslutad
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GlaxoSmithKlineAvslutad
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NovavaxDepartment of Health and Human ServicesAvslutadInfluensa (pandemi)Förenta staterna
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GlaxoSmithKlineAvslutad
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GlaxoSmithKlineAvslutad
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GlaxoSmithKlineAvslutad
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GlaxoSmithKlineAvslutadInfluensa | InfluensavaccinFörenta staterna, Thailand, Kanada
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National Institute of Allergy and Infectious Diseases...Avslutad