HOW SUPPLIED

A single foil blister contains 4 doses of vaccine in a single package.

Storage

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 °F–46.4 °F). Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at 2 °C–8 °C (35.6 °F–46.4 °F).

Manufactured by

Berna Biotech Ltd, Berne, Switzerland

US-Licence No. 1632

Distributed by

Berna Products, Crucell Vaccines, Inc., Coral Gables, FL 33146

Repackaged by

Rebel Distributors Corp, Thousand Oaks, CA 91320

References

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2. Germanier R., E. Fürer. Characteristics of the attenuated oral vaccine strain S. typhi Ty21a. Develop. Biol. Standard 53: 3–7, 1983.

3. Miller S.I., E.L. Hohmann, D.A. Pegues. Salmonella (including Salmonella typhi). In: Principles and practice of infectious diseases. G.L. Mandell, J.E. Bennett, R. Dolin (ed.) fourth edition, Churchill Livingstone Inc. 2013–2033, 1995.

4. Centers for Disease Control. Summary of notifiable diseases, United States 1995. MMWR 44 (Supplement), 1996.

5. Ryan C.A., N.T. Hargrett-Bean, P.A. Blake. Salmonella typhi infections in the United States, 1975–1984: Increasing role of foreign travel. Rev. Infect. Dis. 11: 1–8, 1989.

6. 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: 599–602, 1983.

7. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid Immunization. MMWR 43 (RR-14), 1994.

8. 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: 221–230, 1943.

9. Wahdan M.H., C. Sérié, Y. Cerisier, S. Sallam, R. Germanier. A controlled field trial of live Salmonella typhi strain Ty21a oral vaccine against typhoid: three-year results. J. Infect. Dis. 145: 292–296, 1982.

10. 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 vaccine in enteric-coated capsules in a controlled field trial. Vaccine 8: 81–84, 1990.

11. 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: 1049–1052, 1987.

12. 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): S552–S567, 1989.

13. 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: 766–769, 1989.

14. 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: 1055–1059, 1991.

15. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.

16. 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 as a live oral vaccine. J. Infect. Dis. 136: 717–723, 1977.

17. Cryz S.J. Jr., Post-marketing experience with live oral Ty21a Vaccine. Lancet; 341: 49–50, 1993. Data on File, Swiss Serum and Vaccine Institute Berne, Switzerland.

18. Horowitz H., CA. Carbonaro, Inhibition of the Salmonella typhi oral vaccine strain Ty21a, by mefloquine and chloroquine J. Infect. Dis. 166: 1462–1464, 1992.

19. 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: 871–875, 1997.

20. Vaccine Adverse Event Reporting System – United States. MMWR 39: 730–733, 1990.

21. Levine M.M., R.E. Black, C. Ferreccio, M.L. Clements, C. Lanata, J. Rooney, R. Gemanier. The efficacy of attenuated Salmonella typhi oral vaccine strain Ty21a evaluated in controlled field trials. In: Development of Vaccines and Drugs against Diarrhea. 11th Noble Conference, Stockholm, 1985, p. 90–101. J. Holmgren, A. Lindberg and R. Möllby (eds.). Studentlitteratur, Lund, Sweden, 1986.