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Combined hepatitis A and typhoid vaccine (United States and Canada: Not available): Drug information

Combined hepatitis A and typhoid vaccine (United States and Canada: Not available): Drug information
(For additional information see "Combined hepatitis A and typhoid vaccine (United States and Canada: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • ViVaxim [DSC]
Pharmacologic Category
  • Vaccine;
  • Vaccine, Inactivated (Bacterial);
  • Vaccine, Inactivated (Viral)
Dosing: Adult
Primary immunization

Primary immunization: IM: 1 mL single dose at least 2 weeks prior to expected exposure.

Booster immunization

Booster immunization: May administer 1 mL booster dose 3 years after previous dose in individuals requiring a booster dose based on potential exposure.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Primary immunization

Primary immunization: IM: Adolescents ≥16 years: Refer to adult dosing

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Central nervous system: Headache (15%)

Local: Pain at injection site (90%), induration at injection site (≤28%), swelling at injection site (≤28%), erythema at injection site (10%)

Neuromuscular & skeletal: Weakness (17%), myalgia (16%)

1% to 10%:

Central nervous system: Malaise (3%), dizziness (1%)

Gastrointestinal: Diarrhea (3%), nausea (3%)

Miscellaneous: Fever (5%)

<1%, postmarketing, and/or case reports (reported with ViVAXIM): Arthralgia, pruritus, skin rash

Contraindications

Hypersensitivity to typhoid vaccine, hepatitis A vaccine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2021]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2021]; NACI 2016).

Disease-related concerns:

• Acute illness: Defer administration in patients with acute or febrile illness; may administer to patients with mild acute illness with low-grade fever (NACI 2016).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration (NACI 2016).

• Hepatic impairment: Patients with chronic liver disease may have decreased antibody response.

• Typhoid fever: Should not be used to treat typhoid fever. Not all recipients of typhoid vaccine will be fully protected against typhoid fever. Travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water sources.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2021]).

• Vaccines: Simultaneous administration of other vaccines at different injection sites is not likely to affect immune response. Hepatitis A seroconversion rates are not lower with simultaneous administration of immune globulins (at separate sites) however hepatitis A antibody titers may be lower. In order to maximize vaccination rates, the NACI recommends simultaneous administration of all age-appropriate vaccines for which a person is eligible at a single clinic visit, unless contraindications exist (NACI 2016).

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy (including high dose corticosteroids); may have a reduced response to vaccination. If appropriate, consider delaying administration until after completion of immunosuppressive therapy. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2021]; IDSA [Rubin 2014]).

Dosage form specific issues:

• Neomycin: Formulation may contain neomycin.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and is improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2021]). Due to the long incubation period for hepatitis, unrecognized hepatitis A infection may be present at time of vaccination; immunization may not prevent infection in these patients.

Product Availability

Not available in the US

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension Prefilled Syringe, Intramuscular:

ViVaxim: Salmonella typhi purified Vi capsular polysaccharide 25 mcg and inactivated Hepatitis A virus 160 antigen units per 1 mL ([DSC])

Administration: Adult

Intramuscular: Mix vaccine components immediately before administration according to manufacturer labeling instructions. Shake well until white, cloudy suspension is achieved. Do not administer intravascularly or intradermally. Intramuscular administration into deltoid muscle is preferred. Do not administer to gluteal region. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). Name of medication, date of administration, the vaccine manufacturer, lot number of vaccine, should be entered into the patient's permanent medical record.

May consider subcutaneous administration in individuals at risk of hemorrhage (eg, thrombocytopenia, hemophilia). Subcutaneous administration may be associated with greater risk of injection site reactions. Note: For patients at risk of hemorrhage following intramuscular injection, the NACI recommends weighing the benefits and risks of intramuscular vaccination. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 5 minutes. Patients on low-dose aspirin or long-term anticoagulant therapy (warfarin, heparin) are not considered to be at greater risk of complications and should receive scheduled vaccinations (Ref).

Administration: Pediatric

IM: Administer IM into deltoid muscle; do not administer to gluteal region. Do not administer intravascularly or intradermally. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, adolescents should be vaccinated while seated or lying down (Ref). Name of medication, date of administration, the vaccine manufacturer, lot number of vaccine, should be entered into the patient's permanent medical record.

May consider SubQ administration in individuals at risk of hemorrhage (eg, thrombocytopenia, hemophilia). SubQ administration may be associated with greater risk of injection site reactions. Note: For patients at risk of hemorrhage following IM injection, the NACI recommends weighing the benefits and risks of intramuscular vaccination. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 5 minutes. Patients on low-dose aspirin or long-term anticoagulant therapy (warfarin, heparin) are not considered to be at greater risk of complications and should receive scheduled vaccinations (Ref).

Use: Labeled Indications

Note: Not approved in the US

Salmonella typhi and hepatitis A disease prevention: Active immunization against typhoid fever caused by Salmonella typhi and against disease caused by hepatitis A virus (HAV) in adolescents ≥16 years and adults

National Advisory Committee on Immunizations (NACI) does not recommend use for routine vaccination but does recommend that immunization be considered in the following groups (NACI 2014; NACI 2016):

- Travelers to areas with a prolonged risk (>4 weeks) of exposure to S. typhi or travelers to areas with endemic hepatitis A

- Persons with intimate exposure to a S. typhi carrier or who are residing in communities with high endemic rates of hepatitis A virus or at risk of outbreaks

- Laboratory technicians with frequent exposure to S. typhi or individuals involved in hepatitis A research or production of hepatitis A vaccine

- Travelers with achlorhydria or hypochlorhydria

- Military personnel, relief workers, or others relocated to areas with high rates of hepatitis A infection

- Persons with lifestyle risks for hepatitis A infection (eg, drug abusers, homosexual men), chronic liver disease, receiving hepatotoxic medication or with disease(s) which may necessitate use of hepatotoxic medications

- Persons with hemophilia A or B treated with plasma-derived clotting factors

- Zookeepers, veterinarians, and researchers who handle nonhuman primates

Medication Safety Issues
Sound-alike/look-alike issues:

ViVAXIM may be confused with Vyvanse

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted. Although the safety of this combination vaccine during pregnancy has not been determined, consider use in high risk situations. Inactivated vaccines have not been shown to cause increased risks to the fetus (NACI 2015).

Breastfeeding Considerations

It is not known if this vaccine is present in breast milk. Inactivated vaccines do not affect the safety of breastfeeding for the mother or the infant. Breastfeeding women may be vaccinated when indicated. Breastfeeding infants should be vaccinated according to the recommended schedules (NACI 2015).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2021]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

Provides active immunization against typhoid fever through production of antibodies (predominantly IgG) and against hepatitis A infection through production of antihepatitis A virus antibodies.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Seroprotection rate at 14 days: Hepatitis A: ~96%, typhoid: ~89%; Seroprotection at 28 days: Hepatitis A: ~100%, typhoid: ~90%

Duration: Kinetic models suggest antihepatitis A antibodies may persist ≥20 years (NACI 2016); Typhoid: 3 years

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Hepatyrix | Viatim;
  • (AU) Australia: Vivaxim;
  • (BE) Belgium: Hepatyrix;
  • (CO) Colombia: Vivaxim;
  • (DE) Germany: Hepatyrix | Viatim;
  • (FI) Finland: Viatim;
  • (FR) France: Tyavax;
  • (GB) United Kingdom: Hepatyrix | Viatim;
  • (HK) Hong Kong: Vivaxim;
  • (ID) Indonesia: Vivaxim;
  • (IE) Ireland: Hepatyrix | Viatim;
  • (LU) Luxembourg: Hepatyrix;
  • (MY) Malaysia: Vivaxim;
  • (NO) Norway: Viatim;
  • (NZ) New Zealand: Hepatyrix | Vivaxim;
  • (PE) Peru: Vivaxim;
  • (PT) Portugal: Viatim;
  • (SE) Sweden: Viatim;
  • (ZA) South Africa: Vivaxim
  1. Canadian National Advisory Committee on Immunization (NACI) 2014. https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html.
  2. Canadian National Advisory Committee on Immunization (NACI) 2015. https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html.
  3. Canadian National Advisory Committee on Immunization (NACI) 2016. https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html.
  4. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303‐306. [PubMed 27166466]
  5. Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102‐103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
  6. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  7. Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed April 30, 2021.
  8. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  9. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
  10. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. [PubMed 7746084]
  11. Vivaxim (Combined Purified Vi Polysaccharide Typhoid and Inactivated Hepatitis A vaccine) [Canadian product monograph]. Lyon, France: Sanofi Pasteur SA; September 2015.
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