Journal Article

Estimating Efficacy of Trivalent, Cold-adapted, Influenza Virus Vaccine (CAIV-T) against Influenza A (H1N1) and B Using Surveillance Cultures

M. Elizabeth Halloran, Ira M. Longini, Manjusha J. Gaglani, Pedro A. Piedra, Haitao Chu, Gayla B. Herschler and W. Paul Glezen

in American Journal of Epidemiology

Published on behalf of Johns Hopkins Bloomberg School of Public Health

Volume 158, issue 4, pages 305-311
Published in print August 2003 | ISSN: 0002-9262
Published online August 2003 | e-ISSN: 1476-6256 | DOI: http://dx.doi.org/10.1093/aje/kwg163
Estimating Efficacy of Trivalent, Cold-adapted, Influenza Virus Vaccine (CAIV-T) against Influenza A (H1N1) and B Using Surveillance Cultures

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The authors report on a community-based, nonrandomized, open-label study, conducted during the 2000–2001 influenza season in Temple-Belton, Texas, of the protective effectiveness of trivalent, cold-adapted, influenza virus vaccine (CAIV-T) in children aged 18 months–18 years. The dominant circulating strains in 2000–2001 were influenza A/New Caledonia/20/99 (H1N1) and influenza B/Sichuan/379/99. Children had access to CAIV-T during the 1998–1999, 1999–2000, and 2000–2001 influenza seasons. The vaccine included influenza A/Sydney/5/97 (H3N2) and B/Beijing/184/93-like (B/Ann Arbor/l/94) strains in all three seasons. The vaccine included A/Beijing/262/95 (H1N1) in 1998–1999 and 1999–2000, which was replaced by A/New Caledonia/20/99 (H1N1) in 2000–2001. When medically attended acute respiratory illness (MAARI) was used as the outcome, the protective effectiveness for children vaccinated in 2000 was 18% (95% confidence interval (CI): 11, 25). Based on a combination of a validation sample of surveillance cultures and the MAARI outcome, protective efficacy against combined influenza A (H1N1) and B was 79% (95% CI: 51, 91). The efficacy estimate, after accounting for missing influenza culture status, against influenza A (H1N1) alone was 92% (95% CI: 42, 99) and against a new variant of influenza B alone was 66% (95% CI: 9, 87). CAIV-T provides substantial protection against a mixture of influenza A (H1N1) and B. Results demonstrate the powerful potential of using validation sets for outcomes in vaccine field studies.

Keywords: culture; data collection; data interpretation, statistical; influenza A virus; influenza B virus; influenza vaccine; vaccines; vaccines, attenuated; Abbreviations: CAIV-T, trivalent, cold-adapted, influenza virus vaccine; CI, confidence interval; MAARI: medically attended acute respiratory illness; VES, protective vaccine efficacy; VES,a, vaccine effectiveness estimated by using MAARI as the outcome; VES,v, vaccine efficacy estimated by using surveillance cultures with the mean score method.

Journal Article.  4831 words. 

Subjects: Public Health and Epidemiology

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