title: An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink.
abstract: Using a new sequential analytic method, the safety of tetanus-diphtheria-acellular pertussis (Tdap) vaccine was monitored weekly among subjects aged 10-64 years during 2005-2008. Encephalopathy-encephalitis-meningitis, paralytic syndromes, seizures, cranial nerve disorders, and Guillain-Barré syndrome were selected as outcomes based on previous reports and biologic plausibility. The risk following Tdap was not significantly higher than the risk after Td. Statistical power was sufficient to detect a relative risk of 4-5 for Guillain-Barré syndrome and 1.5-2 for the other outcomes. This study provides reassurance that Tdap is similar in safety to Td regarding the outcomes studied and supports the viability of sequential analysis for post-licensure vaccine safety monitoring.
authors.affiliation: Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA. katherine_yih@harvardpilgrim.org
authors.forename: W Katherine
authors.initials: WK
authors.lastname: Yih
authors.forename: James D
authors.initials: JD
authors.lastname: Nordin
authors.forename: Martin
authors.initials: M
authors.lastname: Kulldorff
authors.forename: Edwin
authors.initials: E
authors.lastname: Lewis
authors.forename: Tracy A
authors.initials: TA
authors.lastname: Lieu
authors.forename: Ping
authors.initials: P
authors.lastname: Shi
authors.forename: Eric S
authors.initials: ES
authors.lastname: Weintraub
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D003389:Cranial Nerve Diseases / Q000139:chemically induced; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects*; D004660:Encephalitis / Q000139:chemically induced; D005260:Female; D020275:Guillain-Barre Syndrome / Q000139:chemically induced; D006801:Humans; D008297:Male; D008581:Meningitis / Q000139:chemically induced; D008875:Middle Aged; D010243:Paralysis / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment / Q000706:statistics & numerical data; D012640:Seizures / Q000139:chemically induced; D055815:Young Adult
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines