Vaccine Information: Typhim Vi (Page 2 of 3)

Concurrently Administered Vaccines

Concomitant Administration of Typhim Vi and Menactra vaccine

In a double-blind, randomized, controlled clinical trial, 945 participants aged 18 through 55 years received Typhim Vi and Menactra vaccines concomitantly (N=469), or Typhim Vi vaccine followed one month later by Menactra vaccine (N=476). Sera were obtained approximately 28 days after each respective vaccination. The antibody response to Typhim Vi vaccine and to Menactra vaccine components were similar between groups.

Typhim Vi Indications and Usage

Typhim Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is approved for use in persons two years of age or older.

Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi.

Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US). (14)

Selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi. (14)

Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water. (15)

There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps. (14)

An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time.

For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section.

Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.

CONTRAINDICATIONS

TYPHIM Vi VACCINE IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF HYPERSENSITIVITY TO ANY COMPONENT OF THIS VACCINE.

WARNINGS

Allergic reactions have been reported rarely in the post-marketing experience (see ADVERSE REACTIONS section).

The safety and immunogenicity of Typhim Vi vaccine in children under two years of age has not been established. As with other polysaccharide vaccines, the antibody response may be inadequate. The decision whether to vaccinate children under 2 years of age depends upon the risk incurred by the child on the basis of the epidemiological context.

Typhim Vi vaccine provides protection against the risk of infection related to Salmonella typhi , but gives no protection against Salmonella paratyphi A or B , non-S typhi species of Salmonella enterica serovar Typhi , or other bacteria that cause enteric disease.

If the vaccine is used in persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, the expected immune response may not be obtained. This includes patients with asymptomatic or symptomatic HIV-infection, severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. (16)

As with any vaccine, vaccination with Typhim Vi vaccine may not protect 100% of individuals.

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of Typhim Vi vaccine.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE FOLLOWING IMMUNIZATION SHOULD AN ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine or similar vaccines.

Acute infection or febrile illness may be reason for delaying use of Typhim Vi vaccine except when, in the opinion of the physician, withholding the vaccine entails a greater risk.

Syncope (fainting) has been reported following vaccination with Typhim Vi. Procedures should be in place to prevent falling injury and manage syncopal reactions.

A separate, sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.

Do not administer intravenously.

Safety and immunogenicity data from controlled trials are not available for Typhim Vi vaccine following previous immunization with whole-cell typhoid or live, oral typhoid vaccine (see ADVERSE REACTIONS section).

INFORMATION FOR VACCINE RECIPIENTS OR PARENTS/GUARDIANS

Before administration, healthcare providers should inform patients, parents or guardians of the benefits and risks of immunization with Typhim Vi vaccine.

Prior to administration of Typhim Vi vaccine, healthcare providers should ask patients, parents and guardians about the recent health status of the patient to be immunized.

Typhim Vi vaccine is indicated in persons traveling to endemic or epidemic areas. Current CDC advisories should be consulted with regard to specific locales.

Travelers should take all necessary precautions to avoid contact with or ingestion of contaminated food and water.

One dose of vaccine should be given at least 2 weeks prior to expected exposure.

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)

As part of the child’s or adult’s immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded. (17)

DRUG INTERACTIONS

There are no known interactions of Typhim Vi vaccine with drugs or foods.

Concomitant Vaccine Administration

Typhim Vi was concomitantly administered with Menactra vaccine in individuals 18 through 55 years of age (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS).

No studies have been conducted in the US to evaluate interactions or immunological interference between the concurrent use of Typhim Vi vaccine and drugs (including antibiotics and antimalarial drugs), immune globulins or other vaccines (including common travelers vaccines such as tetanus, poliomyelitis, hepatitis A, and yellow fever).

Typhim Vi vaccine must not be mixed with any vaccine in the same syringe. Separate injection sites should be used in case of concomitant administration.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Typhim Vi vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility.

PREGNANCY

Animal reproduction studies have not been conducted with Typhim Vi vaccine. It is not known whether Typhim Vi vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Typhim Vi vaccine should be given to a pregnant woman only if clearly needed. (14)

When possible, delaying vaccination until the second or third trimester to minimize the possibility of teratogenicity is a reasonable precaution. (18)

NURSING MOTHERS

It is not known whether Typhim Vi vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Typhim Vi vaccine is administered to a nursing woman.

There is no data on the use of this product in nursing mothers.

PEDIATRIC USE

Safety and effectiveness of Typhim Vi vaccine have been established in children 2 years of age and older. (10) (11) (See DOSAGE AND ADMINISTRATION section.) FOR CHILDREN BELOW THE AGE OF 2 YEARS, SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED.

ADVERSE REACTIONS

Adverse event information is derived from clinical trials and worldwide post-marketing experience.

DATA FROM CLINICAL TRIALS

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.

Safety of Typhim Vi vaccine, the US licensed liquid formulation, has been assessed in clinical trials in more than 4,000 subjects both in countries of high and low endemicity. In addition, the safety of the lyophilized formulation has been assessed in more than 6,000 individuals. The adverse reactions were predominately minor and transient local reactions. Local reactions such as injection site pain, erythema, and induration almost always resolved within 48 hours of vaccination. Elevated oral temperature, above 38°C (100.4°F), was observed in approximately 1% of vaccinees in all studies. No serious or life-threatening systemic events were reported in these clinical trials. (10) (11)

Adverse reactions from two trials evaluating Typhim Vi vaccine lots in the US (18- to 40-year-old adults) are summarized in Table 3. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours. (10) (11)

Table 3 (10) (11): PERCENTAGE OF 18- TO 40-YEAR-OLD US ADULTS PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM Vi VACCINE
REACTION Trial 1PlaceboN = 54 Trial 1Typhim Vi vaccineN = 54(1 Lot) Trial 2Typhim Vi vaccineN = 98(2 Lots combined)
Local
Tenderness 7 (13.0%) 53 (98.0%) 95 (96.9%)
Pain 4 (7.4%) 22 (40.7%) 26 (26.5%)
Induration 0 8 (14.8%) 5 (5.1%)
Erythema 0 2 (3.7%) 5 (5.1%)
Systemic
Malaise 8 (14.8%) 13 (24.0%) 4 (4.1%)
Headache 7 (13.0%) 11 (20.4%) 16 (16.3%)
Myalgia 0 4 (7.4%) 3 (3.1%)
Nausea 2 (3.7%) 1 (1.9%) 8 (8.2%)
Diarrhea 2 (3.7%) 0 3 (3.1%)
Feverish (subjective) 0 6 (11.1%) 3 (3.1%)
Fever ≥100°F 0 1 (1.9%) 0
Vomiting 0 1 (1.9%) 0

No studies were conducted in US children. Adverse reactions from a trial in Indonesia in children one to twelve years of age are summarized in Table 4. (10) (11) No severe or unusual side effects were observed.

Table 4 (10) (11): PERCENTAGE OF INDONESIAN CHILDREN ONE TO TWELVE YEARS OF AGE PRESENTING WITH LOCAL OR SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER THE FIRST IMMUNIZATION WITH TYPHIM Vi VACCINE
REACTIONS N = 175
*
Subjective feeling of fever.
Local
Soreness 23 (13.0%)
Pain 25 (14.3%)
Erythema 12 (6.9%)
Induration 5 (2.9%)
Impaired Limb Use 0
Systemic
Feverishness * 5 (2.9%)
Headache 0
Decreased Activity 3 (1.7%)

In the US Reimmunization Study, subjects who had received Typhim Vi vaccine 27 or 34 months earlier, and subjects who had never previously received a typhoid vaccination, were randomized to placebo or Typhim Vi vaccine, in a double-blind study. Safety data from the US Reimmunization Study are presented in Table 5. (10) (11) (13) In this study 5/30 (17%) primary immunization subjects and 10/45 (22%) reimmunization subjects had a local reaction. No severe or unusual side effects were observed. Most subjects reported pain and/or tenderness (pain upon direct pressure). Local adverse experiences were generally limited to the first 48 hours. (10) (11) (13)

Table 5 (10) (11) (13): US REIMMUNIZATION STUDY, SUBJECTS PRESENTING WITH LOCAL AND SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER IMMUNIZATION WITH TYPHIM Vi VACCINE
REACTION PLACEBO(N = 32) FIRST IMMUNIZATION(N = 30) REIMMUNIZATION(N = 45*)
*
At 27 or 34 months following a previous dose given in different studies.
Local
Tenderness 2 (6%) 28 (93%) 44 (98%)
Pain 1 (3%) 13 (43%) 25 (56%)
Induration 0 5 (17%) 8 (18%)
Erythema 0 1 (3%) 5 (11%)
Systemic
Malaise 1 (3%) 11 (37%) 11 (24%)
Headache 5 (16%) 8 (27%) 5 (11%)
Myalgia 0 2 (7%) 1 (2%)
Nausea 0 1 (3%) 1 (2%)
Diarrhea 0 0 1 (2%)
Feverish (subjective) 0 3 (10%) 2 (4%)
Fever ≥100°F 1 (3%) 0 1 (2%)
Vomiting 0 0 0

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