The safety evaluation of adjuvants during vaccine development: The AS04 experience

Author:

Garçon Nathalie,Segal Lawrence,Tavares Fernanda,Van Mechelen Marcelle

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference58 articles.

1. The perfect mix: recent progress in adjuvant research;Guy;Nat Rev Microbiol,2007

2. GlaxoSmithKline adjuvant systems in vaccines: concepts, achievements and perspectives;Garçon;Expert Rev Vaccines,2007

3. Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies;Brennan;Vaccine,2005

4. European Medicines Agency: Committee for proprietary medicinal products (CPMP). Note for guidance on preclinical pharmacological and toxicological testing of vaccines; 1997. Report no.: CPMP/SWP/465/95. Available from: http://www.ema.europa.eu/pdfs/human/swp/046595en.pdf.

5. Food and Drug Administration (FDA): Center for Biologics Evaluation and Research (CBER). Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies; 1997. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM175909.pdf.

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