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 disordersAsthma
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.
For intramuscular use only.
The immunizing dose for adults and children is a single injection of 0.5 mL.
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 or vial and its packaging should 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, do NOT administer the vaccine.
Picture A: Luer-Lok™ syringe
|Step 1: Holding the syringe cap in one hand (avoid holding the syringe plunger or barrel), unscrew the tip cap by twisting it counterclockwise.|
|Step 2: To attach the needle to the syringe, gently twist the needle clockwise into the syringe until slight resistance is felt.|
The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.
Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic.
Use a separate sterile syringe and needle or a sterile disposable unit for each individual patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of this conditions exists, do NOT administer the vaccine.
In adults, the intramuscular injection is typically given in the deltoid. In children, the intramuscular injection is given either in the deltoid or the anterolateral thigh.
Do NOT inject this vaccine into the gluteal area or areas where there may be a nerve trunk.
Do NOT inject intravenously.
Single-dose syringe, without needle, 0.5 mL, NDC 49281-790-88. Packaged as NDC 49281-790-51.
Multi-dose vial, 20 Dose, NDC 49281-790-38. Packaged as NDC 49281-790-20.
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if the vaccine has been frozen.
- 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 March 2020.
Sanofi Pasteur SA
US Govt License #1724
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
IM only Rx only
Typhoid Vi Polysaccharide Vaccine
Single-dose prefilled syringe
FOR INTRAMUSCULAR ADMINISTRATION.
For indications and directions see enclosed package circular.
prefilled syringe (0.5 mL)
PRINCIPAL DISPLAY PANEL — 20 Dose Vial Label
Vaccine – Typhim Vi®
For indications and directions see
enclosed package insert.
Store at 2° to 8°C (35° to 46°F).
DO NOT FREEZE. DISCARD IF FROZEN.
US Govt License #1724
Sanofi Pasteur SA
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA 1-800-VACCINE (1-800-822-2463)
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