Influenza vaccination of pregnant women protects them over two consecutive influenza seasons in a randomized controlled trial

BACKGROUND We assessed the persistence of hemagglutinin inhibition (HAI) antibodies and the vaccine efficacy (VE) of trivalent inactivated influenza vaccine (IIV3) following vaccination of a cohort of pregnant South African women during a second influenza season. METHODS A cohort of women who participated in a randomized placebo-controlled trial on the safety, immunogenicity and efficacy of IIV3 in 2011 had HAI titers measured in 2012 and were monitored for influenza illness until the end of 2012. RESULTS The proportion of women with HAI titers ≥1:40 was significantly greater in vaccinees (63%) compared to placebo-recipients (22%; p < 0.001). VE in 2012 was 63.8% (95% confidence interval [95%CI]: -33.7%, 90.2%); combined VE for 2011 and 2012 was 58.3% (95%CI: 0.2%, 82.6%). CONCLUSION The majority of women who received IIV3 during pregnancy had HAI titers above the putative threshold for protection against influenza illness one year after vaccination and showed a trend towards protection against influenza disease.