The majority (70%-77%) of solicited injection site reactions at the Typhim Vi and at the Menactra injection sites were reported as Grade 1 and resolved within 3 days post-vaccination. The most common systemic reactions were headache (41% when Menactra and Typhim Vi were given concomitantly; 42% when Typhim Vi was given with Placebo, and 33% when Menactra vaccine was given alone one month after Typhim Vi vaccination) and fatigue (38% when Menactra vaccine and Typhim Vi were given concomitantly; 35% when Typhim Vi was given with Placebo, and 27% when Menactra vaccine was given alone one month after Typhim Vi vaccination). Fever ≥40.0°C and seizures were not reported.
In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Typhim Vi vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Typhim Vi vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.
- Gastrointestinal disorders
Nausea, vomiting, diarrhea, abdominal pain
- General disorders and administration site condition
Injection site pain, inflammation, induration, and erythema; lymphadenopathy, fever, asthenia, malaise, flu-like episode
- Immune system disorders
Anaphylaxis, allergic-type reactions such as pruritus, rash, urticaria, angioedema, difficulty breathing, hypotension; serum sickness
- Musculoskeletal and connective tissue disorders
Myalgia, arthralgia, cervical pain
- Nervous system disorders
Syncope with and without convulsions, headache, loss of consciousness, tremor
- Respiratory system disorders
Post-marketing reports of glomerulonephritis, neutropenia, bilateral retinitis, and polyarthritis have been reported in patients who had also received other vaccines; however, a causal relationship has not been established.
Reporting by parents and patients of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or visit the VAERS website at http//www.vaers.org. (17)
Health-care providers also should report these events to the Pharmocovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, or call 1-800-822-2463.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The syringe or vial and its packaging should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If any of these conditions exists, the vaccine should not be administered.
For intramuscular use only. Do NOT inject intravenously.
The immunizing dose for adults and children is a single injection of 0.5 mL. The dose for adults is typically given intramuscularly in the deltoid, and the dose for children is given IM either in the deltoid or the anterolateral thigh. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk.
A reimmunizing dose is 0.5 mL. Reimmunization consisting of a single dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time. (14)
The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.
The skin at the site of injection first should be cleansed and disinfected. Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess antiseptic before withdrawing vaccine.
NDC: 50090-1758-9 10 mL in a VIAL, MULTI-DOSE / 1 in a PACKAGE
- Levine MM, et al. New knowledge on pathogenesis of bacterial enteric infections as applied to vaccine development. Microbiol. Rev. 47: 510-550, 1983
- Levine MM. Typhoid Fever Vaccines. p 333-361. In Vaccines, Plotkin SA, Mortimer EA, eds. W.B. Saunders, 1988
- Levine MM, et al. Typhoid Fever Chapter 5, In: Vaccines and Immunotherapy. Stanley J. Cryz, Jr., Editor. pp 59-72, 1991
- CDC. Summary of Notifiable Diseases, United States 1992. MMWR 41: No. 55, 1993
- Ryan CA, et al. Salmonella typhi infections in the United States, 1975-1984: Increasing Role of Foreign Travel. Rev Infect Dis 11:1-8, 1989
- Woodruff BA, et al. A new look at typhoid vaccination. Information for the practicing physician. JAMA 265: 756-759, 1991
- Ames WR, et al. Age and sex as factors in the development of the typhoid carrier state, and a method for estimating carrier prevalence. Am J Public Health 33: 221-230, 1943
- CDC. Typhoid fever — Skagit County, Washington. MMWR 39: 749-751, 1990
- Acharya IL, et al. Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi. N Engl J Med 317: 1101-1104, 1987
- Unpublished data available from Sanofi Pasteur Inc., compiled 1991
- Unpublished data available from Sanofi Pasteur SA
- Klugman KP, et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. The Lancet, 1165-1169, 1987
- Keitel WA, et al. Clinical and serological responses following primary and booster immunization with Salmonella typhi Vi capsular polysaccharide vaccines. Vaccines 12: 195-199, 1994
- Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43: No. RR-14, 1994
- CDC. Health Information for International Travel 2001-2002. Atlanta: US Department of Health and Human Services, Public Health Service, 2001
- ACIP: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 42: No. RR-4, 1993
- CDC. Vaccine Adverse Event Reporting System — United States. MMWR 39: 730-733, 1990
- ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991
Product Information as of May 2018.
Sanofi Pasteur SA
US Govt License #1724
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA1-800-VACCINE (1-800-822-2463)
|TYPHIM VI salmonella typhi ty2 vi polysaccharide antigen injection, solution|
|Labeler — A-S Medication Solutions (830016429)|
|A-S Medication Solutions||830016429||RELABEL (50090-1758)|
Revised: 02/2020 A-S Medication Solutions
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