Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study.
Am J Epidemiol
; 177(2): 131-41, 2013 Jan 15.
Article
em En
| MEDLINE
| ID: mdl-23292957
ABSTRACT
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 2008-January 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-Barré 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
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Vacina Antipólio de Vírus Inativado
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Vacina contra Difteria, Tétano e Coqueluche
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Vigilância da População
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Vacinas Anti-Haemophilus
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
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Prognostic_studies
/
Risk_factors_studies
/
Screening_studies
Limite:
Child, preschool
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Female
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Humans
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Infant
/
Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Am J Epidemiol
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Estados Unidos