Safety and Tolerability of a 13-Valent Pneumococcal Conjugated Vaccine Distributed in the Public Immunization Program of the Municipality of Campos dos Goytacazes, Rio de Janeiro, Brazil

Abstract

From september to december, 2010, we have assessed the frequency and occurrence of adverse events to Pneumo-coccal conjugated 13-valent vaccine (PCV-13) in the Public vaccination program of the municipality of Campos dos Goytacazes, State of Rio de Janeiro, the unique city in Brazil that has introduced this vaccine in it’s immunization schedule. This study analyzed 1001 toddlers who have received PCV-13 at 3, 5 and 7 months and a booster dose at 12 months. We observed a total of 514 local and systemic events in 303 subjects (30.2% of 1001 infants). The most reported systemic events were irritability (18.8%) and fever < 38.5°C (17.1%), followed by fever > or = 38.5°C (8.8%), loss of appetite (8.4%). Erythema (11.2%) and local pain (9.4%) were the most reported local events. Other events reported were diarrhea (6.2%), increased sleep (5.1%), edema and induration (4.8%), decreased sleep (4.3%), vomiting (1.4%), eruption (1.2%) urticaria (0.8%), prurience (0.8%), lymphadenopathy (0.2%) and hypersensitivity reaction (0.2%). There wasn’t any reported case of convulsion or Hospital admission. When stratified by each dose, irritability (systemic) and erythema (local) were the most common events reported at the first and fourth dose, although fever < 38.5°C (systemic) and pain (local) were the most common at second and third doses. Results were close to those encountered in product monograph. In our study, PCV-13 was secure in pneumococcal disease prevention and well tolerated.