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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 310,11: 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 1 Placebo
N = 54
|Trial 1 Typhim Vi vaccine
N = 54 (1 Lot)
|Trial 2 Typhim Vi vaccine
N = 98 (2 Lots combined)
|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%)|
|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|
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 410,11: 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|
|Impaired Limb Use||0|
|Decreased Activity||3 (1.7%)|
|* Subjective feeling of fever.|
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 510,11,13: US REIMMUNIZATION STUDY,
SUBJECTS PRESENTING WITH LOCAL AND SYSTEMIC REACTIONS WITHIN 48 HOURS AFTER IMMUNIZATION
WITH TYPHIM Vi VACCINE
(N = 32)
(N = 30)
(N = 45*)
|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%)|
|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%)|
|Feverish (subjective)||0||3 (10%)||2 (4%)|
|Fever ≥ 100°F||1 (3%)||0||1 (2%)|
|* At 27 or 34 months following a previous dose given in different studies.|
Solicited Injection Site And Systemic Reactions When Given With Menactra Vaccine
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.
Data From Worldwide Post-Marketing Experience
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.
Nausea, vomiting, diarrhea, abdominal pain
General Disorders And Administration Site Condition
Immune System Disorders
Musculoskeletal And Connective Tissue Disorders
Nervous System Disorders
Respiratory System Disorders
Additional Adverse Events
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 Of Adverse Events
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 tollfree 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 1-800-8222463.
Read the Typhim (typhoid vi polysaccharide vaccine) Side Effects Center for a complete guide to possible side effects
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, Impariment Of Fertility
Typhim Vi vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility.
Pregnancy Category C
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
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.
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.
10 Unpublished data available from Sanofi Pasteur Inc., compiled 1991
11 Unpublished data available from Sanofi Pasteur SA
13 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
14 Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43: No. RR-14, 1994
17 CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990
18 ACIP: Update on Adult Immunization. MMWR 40: No. RR-12, 1991
Read the Typhim Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/10/2014
Additional Typhim Information
Report Problems to the Food and Drug Administration
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