VIVOTIF- salmonella typhi ty21a_capsule, coated

Salmonella typhi 3 4 5 S. typhi 6 The majority of typhoid cases respond favorably to antibiotic therapy. However, the emergence of multi-drug resistant strains has greatly complicated therapy and cases of typhoid fever that are treated with ineffective drugs can be fatal ( 7 8 S. typhi 3 Virulent strains of S. typhi S. typhi S. typhi 1 S. typhi 1 2 1 2 Results from clinical studies indicate that adults and children greater than 6 years of age may be protected against typhoid fever following the oral ingestion of 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a). The efficacy of the S. typhi 9 10 11 12 13 14 11 16 S. typhi 15 S. typhi S. typhi 15 S. typhi 16

Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi S. typhi S. typhi S. typhi 7 Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella Salmonella typhi S. typhi

One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink on alternate days, e.g., days 1, 3, 5 and 7. Immunization (ingestion of all 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) should be completed at least 1 week prior to potential exposure to S. typhi The blister containing the vaccine capsules should be inspected to ensure that the foil seal and capsules are intact. The vaccine capsule should not be chewed and should be swallowed as soon after placing in the mouth as possible. A complete immunization schedule is the ingestion of 4 vaccine capsules as described above. Re-immunization The optimum booster schedule for Vivotif has not been determined. Efficacy has been shown to persist for at least 5 years. Further, there is no experience with Vivotif as a booster in persons previously immunized with parenteral typhoid vaccine. It is recommended that a re-immunization dose consisting of 4 vaccine capsules taken on alternate days be given every 5 years under conditions of repeated or continued exposure to typhoid fever ( 7

More than 1.4 million doses of Ty21a have been administered in controlled clinical trials and more than 150 million doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) have been marketed world-wide. Active surveillance for adverse reactions of enteric-coated capsules was performed in a pilot study ( 21 14 14 16 Post-marketing surveillance has revealed that adverse reactions are infrequent and mild ( 17 To report SUSPECTED ADVERSE REACTIONS, contact Emergent Travel Health Inc. at 1-800-533-5899, medicalinformation@ebsi.com; or contact the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov.

Hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.

Pregnancy
Category C Animal reproduction studies have not been conducted with Vivotif. It is not known whether Vivotif can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Vivotif should be given to a pregnant woman only if clearly needed.
Nursing Mothers
There is no data to warrant the use of this product in nursing mothers. It is not known if Vivotif is excreted in human milk.
Pediatric Use
The safety and efficacy of Vivotif has not been established in children under 6 years of age. This product is not indicated for use in children under 6 years of age.

Vivotif (Typhoid Vaccine Live Oral Ty21a) is not stable when exposed to ambient temperatures. Vivotif should therefore be shipped and stored between 2 °C and 8 °C (35.6 °Fen dash46.4 °F). Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at 2 °Cen dash8 °C (35.6 °Fen dash46.4 °F).

WARNINGS
Vivotif (Typhoid Vaccine Live Oral Ty21a) is not to be taken during an acute gastrointestinal illness. The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Postpone taking the vaccine if persistent diarrhea or vomiting is occurring. Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms, i.e. travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water.
Carcinogenesis,Mutagenesis, Impairment of Fertility
Long-term studies in animals with Vivotif have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.
References
Germanier R., E. Fürer. Isolation and characterisation of Gal E mutant Ty21a of Salmonella typhi Germanier R., E. Fürer. Characteristics of the attenuated oral vaccine strain S. typhi Miller S.I., E.L. Hohmann, D.A. Pegues. Salmonella Salmonella typhi Centers for Disease Control. Summary of notifiable diseases, United States 1995. MMWR 44 (Supplement), 1996. Ryan C.A., N.T. Hargrett-Bean, P.A. Blake. Salmonella typhi Taylor D.N., R.A. Pollard, P.A. Blake. Typhoid in the United States and the Risk to the International Traveler. J. Infect. Dis. 148: 599en dash602, 1983. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid Immunization. MMWR 43 (RR-14), 1994. Ames W.R., M. Robbins. Age and sex as factors in the development of the typhoid carrier state, and a model for estimating carrier prevalence. Am. J. Public Health 33: 221en dash230, 1943. Wahdan M.H., C. Sérié, Y. Cerisier, S. Sallam, R. Germanier. A controlled field trial of live Salmonella typhi Black R.E., M.M. Levine, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Germanier, Chilean Typhoid Committee. Efficacy of one or two doses of Ty21a Salmonella typhi Levine M.M., C. Ferreccio, R.E. Black, R. Germanier, Chilean Typhoid Committee. Large-Scale Field Trial of Ty21a Typhoid Vaccine Live Oral Ty21a in Enteric-Coated Capsule Formulation. Lancet 1: 1049en dash 1052, 1987. Levine M.M., C. Ferreccio, R.E. Black, C.O. Tacket, R. Germanier, Chilean Typhoid Committee. Progress in vaccines against typhoid fever. Rev. Infect. Dis. 11 (Supplement 3): S552en dashS567, 1989. Ferreccio C., M.M. Levine, H. Rodriguez, R. Contreras, Chilean Typhoid Committee. Comparative efficacy of two, three, or four doses of Ty21a live oral typhoid vaccine in enteric-coated capsules: a field trial in endemic area. J. Infect. Dis. 159: 766en dash769, 1989. Simanjuntak C.H., F.P. Paleologo, N.H. Punjabi, R. Darmowigoto, Soeprawoto, H. Totosudirjo, P. Haryanto, E. Suprijanto, N.D. Witham, S.L. Hoffman. Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine. Lancet 338: 1055en dash1059, 1991. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland. Gilman R.H., R.B. Hornick, W.E. Woodward, H.L. DuPont, M.J. Snyder, M.M. Levine, J.P. Libonati. Evaluation of a UDP-glucose-4-epimeraseless mutant of Salmonella typhi Cryz S.J. Jr., Post-marketing experience with live oral Ty21a Vaccine. Lancet; 341: 49en dash50, 1993. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland. Horowitz H., CA. Carbonaro, Inhibition of the Salmonella typhi Kollaritsch H., J.U. Que, C. Kunz, G. Wiedermann, C. Herzog, S.J. Cryz Jr. Safety and immunogenicity of live oral cholera and typhoid vaccines administered alone or in combination with anti- malarial drugs, oral polio vaccine or yellow fever vaccine. J. Infect. Dis. 175: 871en dash875, 1997. Vaccine Adverse Event Reporting System en dash United States. MMWR 39: 730en dash733, 1990. Levine M.M., R.E. Black, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Gemanier. The efficacy of attenuated Salmonella typhi

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