Investigation of a regulatory agency enquiry into potential porcine circovirus type 1 contamination of the human rotavirus vaccine, Rotarix™: Approach and outcome

Human Vaccines and Immunotherapeutics

Volumn 9, Issue 11, 2013, Pages 2398-2408

  Dubin, Gary ^a   Toussaint, Jean François ^b   Cassart, Jean Pol ^b   Howe, Barbara ^a   Boyce, Donna ^a,c   Friedland, Leonard ^a   Abu Elyazeed, Remon ^a   Poncelet, Sylviane ^b   Han, Htay Htay ^a   Debrus, Serge ^b  

^a GLAXOSMITHKLINE   (United States)

^b GSK   (Belgium)

^c PFIZER INC   (United States)

Author keywords

Adventitious agents; Human rotavirus vaccine; Inactivated poliovirus vaccine; Porcine circovirus type 1; Rotarix

Indexed keywords

POLIOMYELITIS VACCINE; ROTAVIRUS VACCINE; VIRUS DNA; LIVE VACCINE; RIX4414 VACCINE;

ARTICLE; CIRCOVIRIDAE INFECTION; CIRCOVIRUS; DNA DETERMINATION; DNA SEQUENCE; DRUG CONTAMINATION; DRUG EFFICACY; DRUG PURIFICATION; DRUG SAFETY; HUMAN; NONHUMAN; POLYMERASE CHAIN REACTION; RETROSPECTIVE STUDY; RISK ASSESSMENT; VIRAL CONTAMINATION; VIRUS PARTICLE; ANIMAL; CHEMISTRY; GENETICS; ISOLATION AND PURIFICATION; STANDARDS;

ANIMALS; CIRCOVIRUS; DNA, VIRAL; DRUG CONTAMINATION; HUMANS; ROTAVIRUS VACCINES; VACCINES, ATTENUATED;

EID: 84887431948     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.25973     Document Type: Article

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