Efficacy of trivalent, cold-adapted, influenza virus vaccine against influenza A (Fujian), a drift variant, during 2003–2004

Abstract

In the 2003–2004 influenza season, the predominant circulating influenza A (H3N2) virus in the United States was similar antigenically to A/Fujian/411/2002 (H3N2), a drift variant of A/Panama/2007/99 (H3N2), the vaccine strain. That year, a field study of trivalent live-attenuated influenza vaccine (LAIV-T) was conducted in Temple-Belton, Texas, as part of a larger community-based, non-randomized, open-label study in three communities that began in August 1998 [Gaglani MJ, Piedra PA, Herschler GB, Griffith ME, Kozinetz CA, Riggs MW, et al. Direct effectiveness of the trivalent, cold-adapted, influenza virus vaccine (CAIV-T) against the 2000–2001 influenza A (H1N1) and B epidemic in healthy children. Arch Pediatr Adolesc Med 2004;158:65–73; Piedra PA, Gaglani MJ, Kozinetz CA, Herschler G, Riggs M, Griffith M, et al. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine 2005;23:1540–8; Piedra PA, Gaglani MJ, Riggs M, Herschler G, Fewlass C, Watts M, et al. Live attenuated influenza vaccine, trivalent, is safe in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a community-based, nonrandomized, open-label trial. Pediatrics 2005;116:397–407]. Participants were healthy children aged 5–18 years. The analysis here concerns 6403 children in the Scott & White Health Plan (SWHP) database living within zip codes of the Temple-Belton area, of whom 1706 received LAIV-T and 548 received trivalent inactivated vaccine (TIV) in 2003, 983 had been previously vaccinated in 1998–2001, but not in 2002–2003 or 2003, and 3166 had never been vaccinated. The main outcome measure was medically-attended acute respiratory illness (MAARI). Surveillance culture results were incorporated into the analysis to estimate efficacy against culture-confirmed influenza illness. Vaccine effectiveness of LAIV-T against MAARI was 26% (95% confidence interval (CI) 11, 39). Vaccine efficacy of LAIV-T against culture-confirmed influenza illness including surveillance cultures of children in the SWHP database in the validation calculation was 56% (95% CI 24, 84). LAIV-T was cross-protective with a drift variant strain in 2003–2004, evidence that such vaccines could be important for preparing for a pandemic and for annual influenza.