title: Safety of Typhim Vi vaccine in a postmarketing observational study.
abstract: BACKGROUND
  Typhoid fever is endemic in many parts of the world. In the United States, nearly three quarters of all cases are contracted by persons who traveled to regions with endemic disease. Typhim Vi, a vaccine containing the purified cell surface Vi polysaccharide of the Salmonella enterica serovar Typhi, was developed to provide protection against typhoid fever. We present the results of the largest safety study of this Vi vaccine to date.
  
  
  METHODS
  This open-label, descriptive study assessed safety and reactogenicity following the Vi vaccine administration. Coadministration of other vaccines (at separate sites) was permitted, consistent with clinical practice. Participants aged 2 years or older with no known sensitivities to any vaccine component, who received the Vi vaccine, according to label directions, at a participating travel clinic, were eligible to participate. Information was collected on concurrent medications and medical conditions. The occurrence of solicited injection site reactions and systemic reactions was recorded on diary cards for 7 days following vaccination, along with any unsolicited medical events. Serious adverse events were reported for 30 days postimmunization.
  
  
  RESULTS
  A total of 1,204 participants (mean age: 37.2 y, range: 2-82 y, 55% female) were enrolled into the study, and 1,111 completed the 7-day follow-up. The most common solicited reactions were injection site pain [850 of 1,111 (76.5%)], tenderness [838 of 1,111 (75.4%)], and muscle aches [434 of 1,111 (39.1%)]. Fever was reported in 18 (1.6%) of 1,111 participants. Coadministration of other common travel vaccines did not affect reactogenicity profiles, except for an increase in the Vi vaccine injection site redness when two vaccines were administered in the same limb.
  
  
  CONCLUSIONS
  The Vi vaccine was well tolerated in an unselected population, aged 2 to 82 years, presenting to a travel clinic for vaccination.
authors.affiliation: Travelers' Health and Immunization Services, Newton, MA, USA.
authors.forename: Leonard C
authors.initials: LC
authors.lastname: Marcus
authors.forename: James E
authors.initials: JE
authors.lastname: Froeschle
authors.forename: David R
authors.initials: DR
authors.lastname: Hill
authors.forename: Martin S
authors.initials: MS
authors.lastname: Wolfe
authors.forename: Diane
authors.initials: D
authors.lastname: Maus
authors.forename: Bradley
authors.initials: B
authors.lastname: Connor
authors.forename: Alberto M
authors.initials: AM
authors.lastname: Acosta
authors.forename: Edward R
authors.initials: ER
authors.lastname: Rensimer
authors.forename: Alan
authors.initials: A
authors.lastname: Roberts
authors.forename: Kenneth
authors.initials: K
authors.lastname: Dardick
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012449:Safety; D014195:Travel; D014435:Typhoid Fever / Q000517:prevention & control*; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000276:immunology; D014481:United States
chemical_list: D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; C057664:Vi polysaccharide vaccine, typhoid