First-in-human clinical trials with vaccines--what regulators want.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 20829825.
- Also identified by DOI 10.1038/nbt0910-910 and PMC identifier 7096781.
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Abstract
Several factors should be taken into account when it comes to the first exposure of humans to a novel vaccine.
Medical subject headings
- Adjuvants, Immunologic
- Antigens
- Antigens/immunology
- Child
- Clinical Trials as Topic
- Clinical Trials as Topic/legislation & jurisprudence
- Clinical Trials as Topic/standards
- Clinical Trials as Topic/statistics & numerical data
- Dose-Response Relationship, Drug
- Drug and Narcotic Control
- Drug and Narcotic Control/legislation & jurisprudence
- Humans
- Immunity
- Immunity/immunology
- Immunologic Factors
- Immunologic Factors/immunology
- Immunologic Surveillance
- Quality Control
- Risk Assessment
- Vaccination
- Vaccines
- Vaccines/administration & dosage
- Vaccines/immunology
- Vaccines/standards