- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01593709
Volunteer Screening for Vaccine and Antivirals Clinical Trials
Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies
Background:
- Vaccines and antiviral therapies are critical for preventing and treating viral diseases. Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers are healthy and eligible to participate in these studies, they will be screened before the start of the study. This screening may involve a medical history, physical exam, and blood test. Other samples may also be collected. This study will help identify volunteers who are eligible to participate in vaccine or antiviral therapy trials.
Objectives:
- To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus infections.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Screening may begin several months before the start of the clinical trial. Participants may come to the National Institutes of Health clinic one or more times.
- Participants may be screened with a physical exam and medical history. Blood samples will be collected. Other samples may also be collected, including urine, nasal wash, nasal swab, or stool samples. All samples will be stored for reference by the study researchers....
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Maryland
-
Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
INCLUSION CRITERIA:
- Age: 18 years of age or older
- Available to participate for the planned duration of the clinical trial for which the screening is being done
- Able and willing to complete the informed consent process
- Agree to participate in proceduresas needed for the clinical trial screening process.
EXCLUSION CRITERIA:
- A known condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
- Known to be pregnant or breast-feeding, or planning to become pregnant in the near future
- Use of a medication that significantly alters the immune system within the past 6 months or anticipated within the next year (e.g. immunoglobulin, systemic corticosteroids > prednisone equivalent of 10 mg/kg/day)
- Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
- Abuse of illicit drugs, alcohol abuse, or alcohol dependency within the last 6 months
- Known to be infected with HIV or Hepatitis B and/or C.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
---|
Cohort 1
Healthy adults; age 18 or older
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To screen subjects for their eligibility to participate in clinical trials of investigational or licensed vaccines, antiviral products, or live virus challenge studies being evaluated for research purposes.
Tidsram: At every patient contact.
|
Eligibility will be determined.
|
At every patient contact.
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
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
- 120121
- 12-I-0121
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 Normal fysiologi
-
Massachusetts General HospitalRekryteringNormal fysiologiFörenta staterna
-
National Institute of Environmental Health Sciences...Har inte rekryterat ännu
-
National Institute of Neurological Disorders and...RekryteringNormal fysiologiFörenta staterna
-
Assistance Publique - Hôpitaux de ParisRekryteringNormal graviditetFrankrike
-
National Institute of Neurological Disorders and...RekryteringNormal fysiologiFörenta staterna
-
National Institute of Neurological Disorders and...AvslutadNormal fysiologiFörenta staterna
-
National Institute of Neurological Disorders and...Avslutad
-
K. Sreekumaran NairNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Avslutad
-
Tetraphase Pharmaceuticals, Inc.Department of Health and Human ServicesAvslutadNormal drogtoleransFörenta staterna
-
National Center for Complementary and Integrative...Avslutad