TYPHIM Vi®
A Typhoid Fever Vaccine for Patients 2 Years of Age and Older
What is TYPHIM Vi® indicated for?
TYPHIM Vi® is indicated for active immunization against S. typhi, the organism which causes typhoid fever.1
When is immunization with TYPHIM Vi® recommended?
TYPHIM Vi® is recommended for active immunization in persons 2 years of age and older, in the following situations:
- Travellers to endemic or epidemic areas or where sanitary conditions may be doubtful and where travellers may be exposed to potentially contaminated food and water, particularly when prolonged exposure is anticipated.
- Travellers with reduced or absent gastric acid secretion.
- People with ongoing household or intimate exposure to an S. typhi carrier.
- Laboratory workers who frequently handle cultures of S. typhi.
About TYPHIM Vi®
What is the TYPHIM Vi® mechanism of action*?
TYPHIM Vi® contains purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain). TYPHIM Vi® confers significant protection against typhoid fever based on the production of measurable antibodies, predominantly of the IgG class.
Immunity appears within 2 to 3 weeks after injection and lasts around 3 years.
How long before their trip should travellers get immunized for typhoid (S. typhi)?
It is important that travellers visiting areas where a recognized risk of exposure to typhoid fever exists get immunized at least two weeks prior to expected exposure to S. typhi.
As with any vaccine, TYPHIM Vi® may not protect 100% of susceptible individuals.
TYPHIM Vi® will not provide protection against species of Salmonella other than S. typhi or against other bacteria that cause enteric disease.
What are the dosage forms and ingredients of injectable TYPHIM Vi®?
TYPHIM Vi® is supplied as a sterile, clear, and colourless solution ready for intramuscular injection.
It comes as:
- 1 x 0.5 mL pre-filled syringe with one needle
Each 0.5 mL dose is formulated to contain:
25 μg Salmonella typhi (Ty2 strain) purified Vi capsular polysaccharide
Non-medicinal ingredients:
1.1 mg phenol (as preservative)
Up to 0.5 mL isotonic buffer solution
The plunger stopper of the syringe does not contain dry natural latex rubber.
Demonstrated Evidence for TYPHIM Vi®1
What is the efficacy of TYPHIM Vi® against typhoid fever, as shown in a study in Nepal?
A randomized, double-blind, controlled trial in 6,907 patients (6,438 target participants aged 5 to 44 years old). Participants were randomized to receive a 0.5 mL dose of TYPHIM Vi® (n=3,457) or a control vaccine (n=3,450).
Demonstrated Approximately 75% Protective Efficacy of TYPHIM Vi® Against Typhoid Fever in Nepal
Seroconversion rates (measured as a ≥4-fold rise in serum antibodies):
Patients 5–14 years old: 76.9%
Patients 15–44 years old: 79.1%
Patients 44–55 years old: 62.5%
What is the efficacy of TYPHIM Vi® in children, as show in a study in South Africa?
A double-blind, controlled trial in 23,075 children aged 5 to 16 years old. 11,384 patients were immunized with a 0.5 mL dose of TYPHIM Vi® (n=5,692) or a control vaccine (n=5,962), while 11,691 were unvaccinated. A total of 239 cases of blood-culture proven S. typhi infection occurred during the 21-month follow-up period among the 23,075 children participating (5.9 cases per annum, per 1,000 children).
The incidence of typhoid in the TYPHIM Vi® immunized children was significantly lower than in the control vaccinated group (p<0.001).
Cases of Blood-Culture Proven S. typhi During 21-Month Observation Period
Antibody levels remained significantly elevated at 6 and 12 months post-vaccination. Follow-up for 3 years following immunization showed a Vi vaccine efficacy of 50% in the third year.
Protective efficacy in relation to the unvaccinated group was 77.4% and 81.0% after 21 months, calculated immediately and 6 weeks after vaccination, respectively.2
How does immunogenicity of TYPHIM Vi® compare in typhoid-naive vs. typhoid-endemic populations (in a Houston, USA study)?
In immunogenicity trials performed in Houston, Texas, in a racially mixed adult population (N=182), seroconversion rates and antibody levels were demonstrated to be equal to, or greater than, those seen in South Africa or Nepal.
A four-fold rise in antibody levels occurred by 1 week in 60% of subjects, by 2 weeks in 80% of subjects, and by 1 month in 93% of subjects immunized with TYPHIM Vi®.
What is the immunogenicity of TYPHIM Vi® across pediatric age groups, including children under 5, as seen in Indonesia?
Seroconversion rates demonstrated 1 month after vaccination in a double-blind, controlled safety and immunogenicity trial of TYPHIM Vi® in 268 Indonesian children aged 1 to 12 years old.
Although antibody levels to Vi antigen are generally correlated with the protective levels, there are no specific data available to substantiate the efficacy in children 2 to 5 years old. No data are available on revaccination doses in children.
a TYPHIM Vi® is not indicated for use in children under the age of 2 years old.
TYPHIM Vi® Dosage and Administration
What is the dosage of TYPHIM Vi® in children and adults, and how often is revaccination recommended?
Revaccination is recommended every 3 years under conditions of repeated or continuous exposure to S. typhi
Adapted from TYPHIM VI® Product Monograph.
What is the administration and instructions for use for TYPHIM Vi®?
TYPHIM Vi® is for intramuscular use only. Do not inject intravascularly.
The preferred site of injection is the deltoid muscle or the anterolateral aspect of the mid-thigh (vastus lateralis muscle). The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.
Shake the pre-filled syringe well before administering the dose.
Remove the tip cap and attach the provided sterile needle to ensure the vaccine will be delivered intramuscularly.
Needles should not be recapped and should be disposed of according to biohazard waste guidelines.
Please refer to the Product Monograph for complete dosing and administration information.
TYPHIM Vi® Safety Profile
What is the safety profile of TYPHIM Vi® including common adverse reactions (side effects)?
A pooled analysis has been performed on 6 studies sharing the same safety standard integrating data from 1,532 subjects (97 children and adolescents from 2 through 17 years of age and 1,435 adults).
Solicited Adverse Reactions Within 7 Days After Vaccination with TYPHIM Vi® in a controlled, double-blind, safety and immunogenicity trial
b For each reaction, the frequency has been defined by the number of subjects experiencing the reaction divided by the number of subjects with available data.
For a complete list of adverse events, please refer to the TYPHIM Vi® Product Monograph.
As with any vaccine, TYPHIM Vi® may not protect 100% of susceptible individuals.
TYPHIM Vi® will not provide protection against species of Salmonella other than S. typhi or against other bacteria that cause enteric disease.
It is important that travelers to areas where a recognized risk of exposure to typhoid exists get immunized at least two weeks prior to expected exposure to S. typhi.
Resources
Safety Information
What are the contraindications, relevant warnings & precautions, and where can I get the TYPHIM Vi® Product Monograph for more information?
Clinical use:
Pediatrics: TYPHIM Vi® is not authorized for use in children below 2 years of age.
Contraindications:
Should not be administered to anyone with a known systemic hypersensitivity reaction to any component of the vaccine or its container, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing similar components.
Relevant warnings & precautions:
- Syncope has been reported.
- As with any vaccine, immunization with TYPHIM Vi® may not protect 100% of susceptible individuals.
- This vaccine will not provide protection against species of Salmonella other than S. typhi. It is important that travelers to areas where a recognized risk of exposure to typhoid exists get immunized at least two weeks prior to expected exposure to S. typhi.
- For intramuscular use only. Do not inject intravascularly. The preferred site of injection is the deltoid muscle or the anterolateral aspect of the mid-thigh (vastus lateralis muscle). The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.
- Persons with serious acute febrile illness should not be vaccinated until symptoms have abated.
- Caution in patients with coagulation disorders or on anticoagulant therapy.
- Risk of anaphylaxis.
- Immunocompromised persons may not achieve the expected immune response.
- No data are available on the response to TYPHIM Vi® in chronic S. typhi carriers.
- Administration of TYPHIM Vi® during pregnancy is not recommended.
For more information:
Visit Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available through our medical department. Call us at 1-888-621-1146.
* Clinical significance unknown.
- Product Monograph: TYPHIM Vi®. Sanofi Vaccines Canada Ltd. March 8, 2024.
- Klugman KP, Gilbertson IT, Koornhof HJ, Robbins JB, Schneerson R, Schulz D, et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. Lancet. 1987 Nov 21;330(8569):1165-1169. doi:10.1016/S0140-6736(87)91316-X
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