Typhim Vi

Each 0.5 mL immunizing dose contains: Typhoid Vi polysaccharide 0.025 mg; Phenol (preservative) maximum of 1.250 mg; Isotonic buffer solution: sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injection q.s. 0.5 mL.

Pharmacotherapeutic group: Bacterial vaccines. ATC code: J07AP03.
PHARMACOLOGY: This vaccine is prepared from purified Vi capsular polysaccharides of Salmonella typhi.
A double-blind, randomized, controlled efficacy clinical study was conducted in a highly endemic area in Nepal, in children and adults from 5 to 44 years. A total of 3,457 subjects received TYPHIM Vi. Compared with the control group (23 valence-pneumococcal polysaccharide vaccine), vaccine efficacy conferred by a single dose of vaccine TYPHIM Vi was 74% (CI 95%: 49; 87) against blood culture-confirmed cases of typhoid fever throughout the 20 months of active surveillance.
Seroconversion rate (defined as 4-fold rise of anti-Vi antibody levels) was collected in 19 clinical trials. These trials were conducted in endemic and non-endemic areas in adults and children from 2 years of age representing a total of 2,137 evaluable subjects. In the adult population, the seroconversion rate ranged from 62.5% to 100% four weeks after a single injection, with similar magnitude of anti-Vi immune response in non-endemic areas compared to endemic areas. Anti-Vi antibody persistence depends on endemicity, with a trend for better persistence in endemic areas (documented up to 10 years in 83 children at levels equal or above 1 μg/mL considered as a serological indicator of protection against typhoid fever). In non-endemic areas, anti-Vi antibodies persist for 2 to 3 years with rates above 1 μg/mL around 41% after two years and 35.6% after 3 years of vaccination with TYPHIM Vi. Revaccination should be carried out with a maximum interval of 3 years if the subject is still exposed to the risk.
Paediatric population: In a double-blind, randomized, controlled efficacy clinical study conducted in a highly endemic area in South Africa, a total of 5,692 subjects from 5 to 15 years of age received TYPHIM Vi. Compared with the control group (meningococcal polysaccharide vaccine of groups A and C), vaccine efficacy conferred by a single dose of vaccine TYPHIM Vi was 55% (CI 95% : 30 ; 71) against blood culture-confirmed cases of typhoid fever during a 3-year follow-up.
Immunogenicity was assessed in both endemic and non-endemic areas in paediatric population aged from 2 to 17 years. In 9 clinical studies including 733 evaluable children, four weeks after a single injection of TYPHIM Vi, the seroconversion rate ranged from 67% to 100%, with a magnitude of anti-Vi immune response similar to that documented in adult.

This vaccine is based on a constituent (capsular antigen) of the bacteria which causes typhoid fever for person two years of age or older.
Typhoid fever prevention becomes effective approximately 2 to 3 weeks after injection and protection lasts around 3 years.

Posology: RESTRICTED TO ADULTS AND CHILDREN OVER 2 YEARS OF AGE.
A single injection (0.5 mL) by the intramuscular or subcutaneous route with protection lasts around 3 years.
If exposure to risk continues, revaccination will be performed every 3 years.
Vaccination schedule is the same for children and for adults.
A successful extraction operation for one or more vaccine doses from a multidose vial depends essentially on the quality of the handling.
Method of administration: If the vaccine is an adsorbed vaccine, the vial must first of all be shaken gently, to avoid foaming, but sufficiently to obtain a homogenous mixture of the contents. Then, using a sterile syringe fitted with a sterile needle, a single dose is withdrawn from the multidose vial, after disinfecting the outer surface of the vial stopper using a disinfectant. For the subsequent dose(s), the same operation should be repeated.
Between the different withdrawal operations and, in any case, within not more than five minutes after the last dose withdrawn, the vial should be replaced in a refrigerator to keep the product at its normal storage temperature, i.e., between +2°C and +8°C (never place it in a freezer).
The manufacturer's legal liability covers the product up until its use.
The quality of the handling performed by the user to withdraw vaccine doses can affect the quality of a product packaged in a multidose vial.
For this reason, the manufacturer cannot assume responsibility for the product over 24 hours after the first extraction operation unless the vial has been stored, in compliance with the manufacturer's recommendations, at a normal refrigerator temperature.
Thereafter, follow the W.H.O. recommendations which, may be found in UNICEF or PAHO brochures.

The vaccination should not be administered, if the patient is known to be hypersensitive to one of the vaccine components or formaldehyde or to casein (which may be present as traces in each dose, owing to its use during the manufacturing process).
Pregnancy: Inform local doctor. See Use in Pregnancy & Lactation.
Children under 2 years old: Typhoid fever is extremely rare in infants.
This vaccine is not indicated in children under 2 years of age because of the risk of insufficient antibody response.
Vaccination should be postponed in case of acute febrile disease.
If there is any doubt, it is essential to consult the doctor or the pharmacist.

Postpone vaccination in the event of fever or severe infection.
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available, in the event of a rare anaphylactic reaction following administration of the vaccine.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection, especially in adolescents. This may be accompanied by several neurological signs such as transient sight disorders, paresthesia and tonic-clonic limb movements during the recovery phase. It is important that procedures be in place to avoid any injury from faints.
Do not inject by the intravascular route.
This vaccine protects against the risks of infection by Salmonella typhi but not against Salmonella paratyphi A or B or non-typhoidal salmonella.
The immunogenicity of TYPHIM Vi may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited.
Injection must be performed via the subcutaneous route in subjects with thrombocytopenia or bleeding disorders. If there is any doubt, do not hesitate to consult the doctor or the pharmacist.
TYPHIM Vi contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
EFFECT ON ABILITY TO DRIVE AND USE MACHINES: The effects on the ability to drive and use machines have not been studied.

Pregnancy: No reliable animal teratogenic data are available.
Currently, no sufficiently relevant clinical data are available to assess a potential teratogenic or foetotoxic effect of this vaccine when administered during pregnancy.
Therefore, the administration of the vaccine during pregnancy is not recommended. TYPHIM Vi should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits.
Lactation: This vaccine can be used during lactation if the benefit outweighs the risk.

Summary of the safety profile: More than 15,000 subjects received TYPHIM Vi (either in a single injection or as a second injection) in clinical studies.
The most common adverse reaction, in all age groups, was injection site pain. In adults from 18 years of age, myalgia and fatigue were the most frequently reported systemic reactions. In children and adolescents (from 2 to 17 years of age), myalgia and cephalalgia were the most frequently reported systemic reactions.
Most adverse reactions occurred within three days of vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset.
Tabulated list of adverse reactions: The adverse reactions listed as follows come from clinical studies (pooled analysis) and worldwide post-marketing experience. The pooled analysis was performed on 6 recent studies sharing the same safety standard integrating data from 1532 subject (97 children and adolescents from 2 to 17 years of age and 1435 adults).
In each System Organ Class, the adverse events are ranked under headings of frequency, the most common reactions coming first, using the following convention: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10 000, <1/1000), Very rare (<1/10 000) including isolated cases.
Not known: cannot be estimated from available data.
The table as follows summarises the frequencies of adverse reactions recorded after any dose of TYPHIM Vi in children and adolescents from 2 to 17 years of age. (See table.)


Click on icon to see table/diagram/image


The most frequently reported adverse reactions in children and adolescents (from 2 to 17 years of age) were injection site reactions: pain (52.6%), swelling / oedema / induration (16.5%) and erythema (14.4%).
In adults from 18 years of age, the most frequently reported adverse reactions were injection site pain (75.6%), myalgia (47.1%) and fatigue / asthenia (25.0%).

This vaccine can be associated with other common vaccines (hepatitis A, yellow fever, diphtheria, tetanus, poliomyelitis, rabies, meningitis A + C and hepatitis B) during the same vaccination session, using separate injection sites.

Store between +2°C and +8°C (in a refrigerator). Do not freeze.
SHELF LIFE: 3 years.

Vaccines, Antisera & Immunologicals

J07AP03 - typhoid, purified polysaccharide antigen ; Belongs to the class of typhoid bacterial vaccines.

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