title: Immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine: a Phase III, open-label study of adults in Brazil.
abstract: The World Health Organization influenza forecast now includes an influenza B strain from each of the influenza B lineages (B/Yamagata and B/Victoria) for inclusion in seasonal influenza vaccines. Traditional trivalent influenza vaccines include an influenza B strain from one lineage, but because two influenza B lineages frequently co-circulate, the effectiveness of trivalent vaccines may be reduced in seasons of influenza B vaccine-mismatch. Thus, quadrivalent vaccines may potentially reduce the burden of influenza compared with trivalent vaccines. In this Phase III, open-label study, we assessed the immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine (Fluarix™ Tetra) in Brazilian adults (NCT02369341). The primary objective was to assess hemagglutination-inhibition antibody responses against each vaccine strain 21 days after vaccination in adults (aged ≥18-60 years) and older adults (aged >60 years). Solicited adverse events for four days post-vaccination, and unsolicited adverse events and serious adverse events for 21 days post-vaccination were also assessed. A total of 63 adults and 57 older adults received one dose of inactivated quadrivalent influenza vaccine at the beginning of the 2015 Southern Hemisphere influenza season. After vaccination, in adults and older adults, the hemagglutination-inhibition titers fulfilled the European licensure criteria for immunogenicity. In adults, the seroprotection rates with HI titer ≥1:40 were 100% (A/H1N1), 98.4% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria); in older adults were 94.7% (A/H1N1), 96.5% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria). Pain was the most common solicited local adverse events in adults (27/62) and in older adults (13/57), and the most common solicited general adverse events in adults was myalgia (9/62), and in older adults were myalgia and arthralgia (both 2/57). Unsolicited adverse events were reported by 11/63 adults and 10/57 older adults. The study showed that inactivated quadrivalent influenza vaccine was immunogenic and well-tolerated in Brazilian adults and older adults.
authors.affiliation: Centro Paulista de Investigação Clinica, São Paulo, SP, Brazil. Electronic address: criszerb@uol.com.br.
authors.forename: Cristiano A F
authors.initials: CA
authors.lastname: Zerbini
authors.affiliation: Universidade Federal de Minas Gerais, Faculdade de Medicina, Santa Casa de Belo Horizonte, Belo Horizonte, MG, Brazil.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Ribeiro Dos Santos
authors.affiliation: Centro Paulista de Investigação Clinica, São Paulo, SP, Brazil.
authors.forename: Maria
authors.initials: M
authors.lastname: Jose Nunes
authors.affiliation: GlaxoSmithKline Pharmaceuticals Ltd., Bangalore, India.
authors.forename: Jyoti
authors.initials: J
authors.lastname: Soni
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Li
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: Varsha K
authors.initials: VK
authors.lastname: Jain
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Opokua
authors.initials: O
authors.lastname: Ofori-Anyinam
mesh_terms: D000328:Adult; D000367:Age Factors; D000914:Antibodies, Viral / Q000097:blood; D001938:Brazil; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006387:Hemagglutination, Viral / Q000276:immunology; D006801:Humans; D000071497:Immunogenicity, Vaccine; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D013997:Time Factors; D016896:Treatment Outcome; D014611:Vaccination / Q000009:adverse effects; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Adults; Brazil; Immunogenicity; Influenza; Quadrivalent; Safety; Vaccine