Am J Epidemiol 2003; 158:305-311.
Copyright © 2003 by Johns
Hopkins Bloomberg School of Public Health
ORIGINAL CONTRIBUTIONS |
Estimating Efficacy of Trivalent, Cold-adapted, Influenza Virus Vaccine (CAIV-T) against Influenza A (H1N1) and B Using Surveillance Cultures
1 Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA.
2 Section of Pediatric Infectious Diseases, Department of Pediatrics, Scott & White Memorial Hospital & Clinic, Scott, Sherwood and Brindley Foundation, The Texas A & M University Health Science Center College of Medicine, Temple, TX.
3 Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX.
4 Department of Pediatrics, Baylor College of Medicine, Houston, TX.
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.
culture; data collection; data interpretation, statistical; influenza A virus; influenza B virus; influenza vaccine; vaccines; vaccines, attenuated
Abbreviations: 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.
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