- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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....
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Cohort 1
Healthy adults; age 18 or older
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: At every patient contact.
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Eligibility will be determined.
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At every patient contact.
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 120121
- 12-I-0121
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