- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02593071
Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
-
Redding, California, Förenta staterna, 96001
- Nothern California Clinical Research
-
-
Georgia
-
Stockbridge, Georgia, Förenta staterna, 30281
- Clinical Research Atlanta
-
-
Kansas
-
Lenexa, Kansas, Förenta staterna, 66219
- Johnson County Clin-Trials
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44122
- Rapid Medical Research
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37203
- Clinical Research Associates
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75234
- Research Across America
-
San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas
-
-
Utah
-
West Jordan, Utah, Förenta staterna, 84088
- Advanced Clinical Research
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98101
- Group Health Research Institute
-
-
Wisconsin
-
Wausau, Wisconsin, Förenta staterna, 54401
- Marshfield Clinical Research Foundation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Absence of changes in medical therapy within one month due to treatment failure or toxicity,
- Absence of medical events qualifying as SAEs within two months, and
- Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
- Access to inbound and outbound communication by telephone with caregivers and study staff.
Exclusion Criteria:
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
- Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
- Any known or suspected immunosuppressive condition, acquired or congenital, 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 ≥10mg 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. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
- 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, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
|
|
Placebo-jämförare: Behandlingsgrupp B
Fosfatbuffert placebo (0,5 ml injektion)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Tidsram: Day 0 to Day 364
|
Derived/calculated endpoints based on these data will include:
|
Day 0 to Day 364
|
Numbers and percentages of subjects with solicited local and systemic AEs
Tidsram: Day 0 to Day 364
|
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2).
In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
|
Day 0 to Day 364
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Tidsram: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Tidsram: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups.
Tidsram: Day 0 to Day 182
|
Day 0 to Day 182
|
Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR.
Tidsram: Day 0 to Day 182
|
Day 0 to Day 182
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- RSV-E-202
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
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 Respiratory Syncytial Virus (RSV)
-
MedImmune LLCAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
Enanta Pharmaceuticals, IncRekryteringRespiratory Syncytial Virus (RSV)Förenta staterna, Spanien, Israel, Australien, Tyskland, Korea, Republiken av, Taiwan, Storbritannien, Argentina, Brasilien, Nya Zeeland, Polen, Rumänien, Sydafrika, Mexiko
-
NovavaxAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
NovavaxAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
VaxartAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
University of RochesterAktiv, inte rekryterandeRespiratory Syncytial Virus (RSV)Förenta staterna
-
University of OxfordInnovative Medicines Initiative; Respiratory syncytial virus consortium...Aktiv, inte rekryterandeRespiratory Syncytial Virus (RSV)Storbritannien
-
Enanta Pharmaceuticals, IncAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
GlaxoSmithKlineAvslutadRespiratory Syncytial Virus (RSV)Belgien
Kliniska prövningar på RSV-F-vaccin
-
NovavaxPATHAvslutad
-
NovavaxAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
NovavaxAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
Blue Lake Biotechnology Inc.AvslutadSyncytialvirusinfektioner i luftvägarnaFörenta staterna
-
NovavaxBill and Melinda Gates FoundationAvslutadSyncytialvirusinfektioner i luftvägarnaFörenta staterna, Argentina, Australien, Bangladesh, Chile, Mexiko, Nya Zeeland, Filippinerna, Sydafrika, Spanien, Storbritannien
-
VaxartAvslutadRespiratory Syncytial Virus (RSV)Förenta staterna
-
NovavaxAvslutadSyncytialvirusinfektioner i luftvägarnaFörenta staterna
-
NovavaxAvslutadRespiratory Synctial VirusKanada
-
GlaxoSmithKlineAvslutadInfektioner, respiratoriskt syncytialvirusKanada
-
NovavaxAvslutad