Approaches to demonstration of Ebola virus vaccine efficacy

The Lancet Infectious Diseases

Volumn 15, Issue 6, 2015, Pages 627-629

  Krause, Philip R ^a   Cavaleri, Marco ^b   Coleman, Gina ^c   Gruber, Marion F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c HEALTH CANADA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EBOLA VACCINE; BIOLOGICAL MARKER;

CANADA; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; EBOLA HEMORRHAGIC FEVER; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MORBIDITY; NONHUMAN; NOTE; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PRODUCT DEVELOPMENT; PUBLIC HEALTH PROBLEM; RANDOMIZED CONTROLLED TRIAL (TOPIC); VACCINATION; WORKSHOP; BIOSTATISTICS; EBOLAVIRUS; HEMORRHAGIC FEVER, EBOLA; IMMUNOLOGY; PROCEDURES; TREATMENT OUTCOME;

BIOLOGICAL MARKERS; BIOSTATISTICS; EBOLA VACCINES; EBOLAVIRUS; HEMORRHAGIC FEVER, EBOLA; HUMANS; TREATMENT OUTCOME;

EID: 84929455557     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)00027-4     Document Type: Note

References (5)

1. Code of Federal Regulations (CFR) title 21, 2014 US Food and Drug Administration, (accessed April 24, 2015). http://www.ecfr.gov/cgi-bin/text-idx?node=pt21.7.601.
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3. REGULATION (EC) No 507/2006. Official Journal of the European Union 2006, L92:6-9. European Union.
4. REGULATION (EC) No 726/2004. Official Journal of the European Union 2004, L136:1-33. European Union.
5. Krause PR, Bryant P, Clark T, et al. Immunology of protection from Ebola virus infection. Sci Transl Med 2015, 7:286ps11.