Evaluation of two yellow fever vaccines for routine immunization programs in Argentina.

Although highly effective vaccines have been available for almost 70 years, an estimated 200,000 cases of YF, including 30,000 deaths, still occur annually. This study evaluated the safety of two yellow fever (YF) vaccines (StamarilTM® and “Vacina Contra A Febre Amarela” [VCFA]). A total of 2,514 subjects were randomized equally to receive StamarilTM or VCFA. Immediate reactions occurring within 30 minutes after vaccination, and solicited local and systemic reactions occurring within 8 days, were monitored. Unsolicited local, systemic adverse events and serious adverse events (SAE) were recorded for 21 days after vaccination. Solicited local and systemic adverse reactions were reported by 15.3–17.6% and 30.4–31.6% of the StamarilTM and VCFA groups, respectively. Only 56 of the 2,514 study subjects (2.2%) reported a severe solicited adverse reaction, 25 in the StamarilTM group (1.99%), and 31 in the VFCA group (2.49%), (p=0.403). Ten subjects (0.8%) in each group reported at least one severe solicited loca...