期刊
AMERICAN JOURNAL OF EPIDEMIOLOGY
卷 177, 期 2, 页码 131-141出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/aje/kws317
关键词
managed care programs; population surveillance; safety; sequential analysis; vaccines; combined
资金
- America's Health Insurance Plans, Centers for Disease Control and Prevention [200-2002-00732]
- Sanofi Pasteur
- Glaxo-Smith-Kline
- Pfizer
- Novartis
- Merck
To address gaps in traditional postlicensure vaccine safety surveillance and to promote rapid signal identification, new prospective monitoring systems using large health-care database cohorts have been developed. We newly adapted clinical trial group sequential methods to this observational setting in an original safety study of a combination diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) conjugate vaccine (DTaP-IPV-Hib) among children within the Vaccine Safety Datalink population. For each prespecified outcome, we conducted 11 sequential Poisson-based likelihood ratio tests during September 2008January 2011 to compare DTaP-IPV-Hib vaccinees with historical recipients of other DTaP-containing vaccines. No increased risk was detected among 149,337 DTaP-IPV-Hib vaccinees versus historical comparators for any outcome, including medically attended fever, seizure, meningitis/encephalitis/myelitis, nonanaphylactic serious allergic reaction, anaphylaxis, Guillain-Barr syndrome, or invasive Hib disease. In end-of-study prespecified subgroup analyses, risk of medically attended fever was elevated among 1- to 2-year-olds who received DTaP-IPV-Hib vaccine versus historical comparators (relative risk 1.83, 95 confidence interval: 1.34, 2.50) but not among infants under 1 year old (relative risk 0.83, 95 confidence interval: 0.73, 0.94). Findings were similar in analyses with concurrent comparators who received other DTaP-containing vaccines during the study period. Although lack of a controlled experiment presents numerous challenges, implementation of group sequential monitoring methods in observational safety surveillance studies is promising and warrants further investigation.
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