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Safety of Typhim Vi vaccine in a postmarketing observational study.
J Travel Med. 2007 Nov-Dec; 14(6):386-91.JT

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+Show Affiliations

Travelers' Health and Immunization Services, Newton, MA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17995534

Citation

Marcus, Leonard C., et al. "Safety of Typhim Vi Vaccine in a Postmarketing Observational Study." Journal of Travel Medicine, vol. 14, no. 6, 2007, pp. 386-91.
Marcus LC, Froeschle JE, Hill DR, et al. Safety of Typhim Vi vaccine in a postmarketing observational study. J Travel Med. 2007;14(6):386-91.
Marcus, L. C., Froeschle, J. E., Hill, D. R., Wolfe, M. S., Maus, D., Connor, B., Acosta, A. M., Rensimer, E. R., Roberts, A., & Dardick, K. (2007). Safety of Typhim Vi vaccine in a postmarketing observational study. Journal of Travel Medicine, 14(6), 386-91.
Marcus LC, et al. Safety of Typhim Vi Vaccine in a Postmarketing Observational Study. J Travel Med. 2007 Nov-Dec;14(6):386-91. PubMed PMID: 17995534.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of Typhim Vi vaccine in a postmarketing observational study. AU - Marcus,Leonard C, AU - Froeschle,James E, AU - Hill,David R, AU - Wolfe,Martin S, AU - Maus,Diane, AU - Connor,Bradley, AU - Acosta,Alberto M, AU - Rensimer,Edward R, AU - Roberts,Alan, AU - Dardick,Kenneth, PY - 2007/11/13/pubmed PY - 2008/2/22/medline PY - 2007/11/13/entrez SP - 386 EP - 91 JF - Journal of travel medicine JO - J Travel Med VL - 14 IS - 6 N2 - 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. SN - 1195-1982 UR - https://www.unboundmedicine.com/medline/citation/17995534/Safety_of_Typhim_Vi_vaccine_in_a_postmarketing_observational_study_ L2 - https://academic.oup.com/jtm/article-lookup/doi/10.1111/j.1708-8305.2007.00158.x DB - PRIME DP - Unbound Medicine ER -