title: Comparison of adverse events following immunization with pandemic influenza A (H1N1)pdm09 vaccine with or without adjuvant among health professionals in Rio de Janeiro, Brazil.
abstract: A vaccination campaign against pandemic influenza A (H1N1)pdm09 was held in Brazil in March 2010, using two types of monovalent split virus vaccines: an AS03-adjuvanted vaccine and a non-adjuvanted vaccine. We compared the reactogenicity of the vaccines in health professionals from a Clinical Research Institute in Rio de Janeiro, Brazil and there were no serious adverse events following immunization (AEFI) among the 494 subjects evaluated. The prevalence of any AEFI was higher in the AS03-adjuvanted vaccine at 2 h and 24 h post-vaccination [preva-lence ratio (PR): 2.05, confidence interval (CI) 95%: 1.55-2.71, PR: 3.42, CI 95%: 2.62-4.48, respectively]; however, there was no difference between the vaccines in the assessments conducted at seven and 21 days post-vaccination. The group receiving the AS03 post-adjuvanted vaccine had a higher frequency of local reactions at 2 h (PR: 3.01, CI 95%: 2.12-4.29), 24 h (PR: 4.57, CI 95%: 3.29-6.37) and seven days (PR: 6.05, CI 95%: 2.98-12.28) post-vaccination. We concluded that the two types of vaccines caused no serious AEFI in the studied population and the adjuvanted vaccine was more reactogenic, particularly in the 24 h following vaccination. This behaviour must be confirmed and better characterised by longitudinal studies in the general population.
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas, Fiocruz, Rio de Janeiro, Brasil. cerbino@fiocruz.br
authors.forename: José
authors.initials: J
authors.lastname: Cerbino-Neto
authors.forename: Ananza Tainá da Silva
authors.initials: AT
authors.lastname: Santos
authors.forename: Maria Isabel Fragoso da Silveira
authors.initials: MI
authors.lastname: Gouvea
authors.forename: Renata Saraiva
authors.initials: RS
authors.lastname: Pedro
authors.forename: Grazielle Viana
authors.initials: GV
authors.lastname: Ramos
authors.forename: Lusiele
authors.initials: L
authors.lastname: Guaraldo
authors.forename: Guilherme Loureiro
authors.initials: GL
authors.lastname: Werneck
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology*; D001938:Brazil; D005260:Female; D006282:Health Personnel; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines