title: Post-marketing evaluation of the short term safety of COMVAX.
abstract: We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB and Liquid PedvaxHIB, COMVAX. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events"; "Gastroenteritis"; "Adverse Effect of Medicinal and Biological Substance, NOS"; and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R(-)II. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.
authors.affiliation: Group Health Cooperative, Center For Health Studies, 1730 Minor Avenue, Suite 1600, Seattle, WA 98195, USA. rdavis@u.washington.edu
authors.forename: Robert L
authors.initials: RL
authors.lastname: Davis
authors.forename: Steven
authors.initials: S
authors.lastname: Black
authors.forename: Henry
authors.initials: H
authors.lastname: Shinefield
authors.forename: Lisa
authors.initials: L
authors.lastname: Mahoney
authors.forename: Ann
authors.initials: A
authors.lastname: Zavitkovsky
authors.forename: Edwin
authors.initials: E
authors.lastname: Lewis
authors.forename: Alex
authors.initials: A
authors.lastname: Nikas
authors.forename: Harry
authors.initials: H
authors.lastname: Guess
authors.forename: Paul
authors.initials: P
authors.lastname: Coplan
mesh_terms: D005260:Female; D005334:Fever / Q000453:epidemiology; D005500:Follow-Up Studies; D005759:Gastroenteritis / Q000453:epidemiology; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D011358:Product Surveillance, Postmarketing; D012140:Respiratory Tract Diseases / Q000453:epidemiology; D018570:Risk Assessment; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D018073:Haemophilus Vaccines; D018074:Vaccines, Conjugate; D014614:Vaccines, Synthetic