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Infanrix

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Infanrix

Infanrix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) (also called DTaP) is used to help prevent these diseases in children who are ages 6 weeks to 6 years old (before the child has reached his or her 7th birthday). This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. It will not treat an active infection that has already developed in the body. Common side effects include fever or chills, redness, pain, tenderness, or swelling where the shot was given, fussiness or crying, joint pain, body aches, loss of appetite, nausea, diarrhea, or vomiting.

A 0.5 mL dose of Infanrix is administered by intramuscular injection in infants and children 6 weeks to 7 years of age as a 5 dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age, followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. Infanrix may interact with steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements your child uses, and other vaccines your child has recently received. Infanrix should not be given to anyone over the age of 6 years old and would not be used in pregnant or nursing women. Another vaccine is available for use in older children and adults.

Our Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Infanrix in Detail - Patient Information: Side Effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the child's doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has a serious side effect such as:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • mild fever or chills;
  • redness, pain, tenderness, or swelling where the shot was given;
  • mild fussiness or crying;
  • joint pain, body aches;
  • loss of appetite; or
  • mild nausea, diarrhea, or vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Infanrix FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Approximately 92,000 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) have been administered in clinical studies. In these studies, 28,749 infants have received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) in primary series studies, 5,830 children have received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) as a fourth dose following 3 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) , and 511 children have received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) as a fifth dose following 4 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) . In addition, 439 children and 169 children have received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) as a fourth or fifth dose following 3 or 4 doses of whole-cell DTP vaccine, respectively. In comparative studies, the first 4 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) have been shown to be followed by fewer of the local and systemic adverse reactions commonly associated with whole-cell DTP vaccination.14 However, studies have shown that the rate of local injection site reactions (erythema and swelling) and fever increased with successive doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) .

In the double-blind, randomized comparative trial in Italy, safety data in a 3-dose primary series are available for 4,696 infants who received at least one dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and 4,678 infants who received at least one dose of US-licensed whole-cell DTP vaccine manufactured by Connaught Laboratories, Inc.6,14 Data were actively collected by parents using standardized diaries for 8 consecutive evenings after each vaccine dose with follow-up telephone calls made by nurses after the eighth day. Table 1 lists adverse events reported during the 3 days after each dose. All common solicited adverse events were less frequent following vaccination with INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) as compared to whole-cell DTP after each 1 of the 3 doses.

Table 1.6 Adverse Events (%) Occurring Within the 3 Days Following Vaccination of Italian Infants With Either INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) or Whole-Cell DTP at 2, 4, and 6 Months of Age

  INFANRIX Whole -Cell DTP Vaccine
Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3
No. of infants 4,696 4,560 4,505 4,678 4,474 4,368
Local
  Redness 4.8 8.6 16.0 27.1 24.2 28.0
  Redness ≥ 2.4 cm 1.0 1.3 3.5 12.4 7.3 7.7
  Swelling 5.2 8.2 14.5 28.9 23.5 25.8
  Swelling ≥ 2.4 cm 0.7 1.2 2.9 13.1 7.4 8.0
  Tenderness 4.7 4.0 5.2 36.0 26.8 25.9
Systemic
  Fever ( ≥ 100.4°F)* 7.1 7.9 9.0 46.8 36.1 39.8
  Irritability 36.3 34.9 28.8 57.2 50.1 47.2
  Drowsiness 34.9 18.8 11.4 54.0 34.1 23.0
  Loss of Appetite 16.5 13.9 11.5 31.2 22.8 19.1
  Vomiting 5.8 4.1 3.3 6.7 4.7 4.8
  Crying ≥ 1 Hour 3.9 3.3 2.2 17.3 11.1 8.2
* Rectal temperatures.
For the comparison of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and whole-cell DTP vaccine, all adverse events reached statistical significance (p < 0.001) at all doses except vomiting at doses 1 and 2, which was not statistically significant at p < 0.05.

A similar reduction in adverse events was seen in a randomized, double-blind, comparative trial conducted in the United States when INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) was compared to 2 US-licensed whole-cell DTP vaccines. Adverse events were actively solicited using standardized diaries with follow-up telephone calls made at days 1, 4, and 8 by blinded study personnel. Table 2 summarizes the frequency of adverse events within 3 days of the three primary immunizing doses. The incidence of redness, swelling, pain, fever (rectal temperature > 101°F), fussiness, drowsiness, and poor appetite were lower following INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) than following either whole-cell DTP vaccine.

Table 2.15 Adverse Events (%) Occurring Within the 3 Days Following Vaccination of US Infants With Either INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) or Whole-Cell DTP at 2, 4, and 6 Months of Age

No. of infants INFANRIX Whole-Cell DTP Vaccine-Lederle Whole-Cell DTP Vaccine-Connaught
Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3
407 402 395 74 73 73 76 75 74
Local
  Redness* 10.6 19.4 25.8 28.4 42.5 39.7 35.5 50.7 50.0
  Swelling 7.4†¶ 12.2†¶ 17.5 23.0 26.0 27.4 30.3 37.3 31.1
  Pain* 2.7 2.0 1.5 17.6 15.1 9.6 38.2 17.3 14.9
Systemic
  Fever ( > 101°F)§ 0.5†¶ 0.7†¶ 5.1 12.2 8.2 6.8 14.5 18.7 8.1
  Fussiness** 3.9†¶ 3.5†¶ 4.1 25.7 13.7 6.8 21.1 16.0 8.1
  Drowsiness 26.3†¶ 16.4†¶ 12.9 51.4 34.2 23.3 52.6 28.0 18.9
  Poor Appetite 8.1†¶ 7.7 6.6 31.1 15.1 9.6 19.7 14.7 9.5
  Vomiting 6.6 3.7 3.8 8.1 4.1 2.7 7.9 2.7 2.7
Moderate or severe = cried or protested to touch or cried when leg moved.
** Moderate or severe = prolonged crying and refusal to play or persistent crying that could not be comforted.
§ Rectal temperatures.
* p < 0.05 for the comparison of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and both whole-cell DTP vaccines.
p < 0.05 for the comparison of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and whole-cell DTP vaccine-Lederle.
p < 0.05 for the comparison of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and whole-cell DTP vaccine-Connaught.

The frequencies of adverse events following each dose in children who received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) at 2, 4, and 6 months of age in a US NIH-sponsored trial are shown in Table 3. Of the 120 infants who received the 3-dose primary series, a subset of 76 received a fourth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) at 15 to 20 months of age and 22 of the 76 received a fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) at 4 to 6 years of age. Adverse events were actively solicited using standardized diaries with follow-up telephone calls made at day 3 by blinded study personnel.

Table 3.14,16,17,18 Adverse Events (%) Occurring Within the 3 Days Following Vaccination With INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) in US Infants and Children in Which All Doses Were INFANRIX (diphtheria and tetanus toxoids and acellular pertussis)

Event Primary Booster  
(N = 120 infants) (N = 76 children) (N = 22 children)
Dose 1
(2 months)
Dose 2
(4 months)
Dose 3
(6 months)
Dose 4
(15 to 20 months)
Dose 5
(4 to 6 years)
Local
  Redness 16.6 15.4 26.3 39.5 59.1
  Swelling 12.5 15.4 21.0 32.9 50.0
  Pain* 5.0 5.1 0.9 10.5 27.3
Systemic
  Fever ( ≥ 101.1°F) 0.0 0.9 3.5 6.6 4.6
  Anorexia 7.5 6.0 9.6 11.8 NR
  Vomiting 5.8 6.8 3.5 2.6 NR
  Drowsiness 37.5 19.7 13.2 6.6 NR
  Fussiness 3.3 7.7 8.8 9.2 0.0
* Moderate or severe = cried or protested to touch or cried when limb moved.
Rectal temperatures for primary series and Dose 4; oral temperatures for Dose 5.
Moderate or severe = prolonged crying and refusal to play or persistent crying that could not be comforted. For Dose 5, the solicited adverse event was irritability; however the definition for this term was the same as for fussiness.
NR = not reported in publication.

Of 22,505 children who had previously received 3 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) at 3, 4, and 5 months of age in the German safety study, 5,361 received a fourth dose at 10 to 36 (mean 20) months of age. Standardized diaries were available on 2,457 children receiving the primary series and 1,809 children receiving the fourth dose. Rates of local and systemic adverse events within 3 days of vaccination for each dose are reported in Table 4. In this study, the rate of erythema, swelling, pain, and fever increased with successive doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) .

Table 4.14 Adverse Events (%) Occurring Within the 3 Days Following Vaccination With INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) in German Infants and Children in Which All Doses Were INFANRIX (diphtheria and tetanus toxoids and acellular pertussis)

Event Primary
(N = 2,457 infants)
Booster
(N = 1,809 children)*
Dose 1
(3 months)
Dose 2
(4 months)
Dose 3
(5 months)
Dose 4
(10 to 36 months)
Local
  Redness 8.9 23.6 26.6 45.9
  Redness > 2 cm 0.0 0.5 1.3 13.8
  Swelling 3.9 14.1 18.5 35.4
  Swelling > 2 cm 0.0 0.3 1.3 11.4
  Pain 2.0 2.6 3.7 26.3
Systemic
  Fever ( ≥ 100.4°F) 6.3 8.3 13.3 26.4
  Fever ( > 103.1°F) 0.0 0.1 0.1 1.1
  Loss of Appetite 8.0 7.4 6.5 11.6
  Vomiting 4.3 3.9 3.4 2.9
  Restlessness 10.3 9.5 8.6 15.9
  Unusual Crying 3.9 4.3 4.1 6.4
  Diarrhea 6.0 4.9 4.0 11.0
* May not be same children as in primary series.
Mean = 20 months.
Rectal temperatures.

INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) administered as a fifth dose in children 4 to 6 years of age previously vaccinated with 4 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) was evaluated in 2 studies conducted in Germany.14 Safety data are available for 93 children from Study A, a randomized and single (subject)-blinded trial and for 390 children from Study B, a non-randomized, open trial (see Table 5). Adverse events in both studies were actively solicited using standardized diary cards to record specific adverse events that occurred during the 15 days following vaccination. Note that most children who received a fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) in these studies had received the fourth dose in the German study described earlier. However, the children included in Table 5 may not be the same children who are included in Table 4.

Rates of solicited local and systemic adverse events within 3 days of vaccination are reported in Table 5. Higher rates of local injection site reactions (redness, swelling, and pain) were observed following a fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) compared with the fourth dose (see Table 4 and Table 5). The reported sizes of local redness and swelling tended to be greater following the fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) compared with the fourth dose (see Table 4 and Table 5).

Table 5. Adverse Events (%) Occurring Within the 3 Days Following Vaccination* With INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) Administered at 4 to 6 Years of Age in German Children Who Had Previously Received 4 Doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis)

  Study A
(N = 93)
Study B
(N = 390)
Local
  Redness, any 51.6 52.1
  Redness, ≥ 50 mm 23.7 29.2
  Redness, ≥ 110 mm 4.3 6.4
  Swelling, any 43.0 49.5
  Swelling, ≥ 50 mm 15.1 20.0
  Swelling, ≥ 110 mm 4.3 5.1
  Pain, any 64.5 49.7
  Pain, grade 2 or 3 20.4 13.8
  Pain, grade 3 1.1 1.5
Systemic
  Fever, ≥ 99.5°F 12.9 11.3
  Fever1, ≥ 102.4°F 0.0 0.0
  Loss of appetite 14.0 10.3
  Vomiting 0.0 2.1
  Irritability 18.3 14.1
  Diarrhea 4.3 3.8
N = number of infants in a modified intent-to-treat (ITT) cohort (infants who received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) for their fifth dose of DTaP whose previous 4 doses of DTaP were all with INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) , for whom at least one symptom sheet was completed; 2 subjects from Study B were excluded due to chronic illnesses that could have interfered with safety assessments).
Grade 2 pain defined as sufficiently discomforting to interfere with daily activities.
Grade 3 pain defined as preventing normal daily activities and needing medical advice.
* Within 3 days of vaccination defined as day of vaccination and the next 2 days.
Axillary temperatures.

Cases of extensive swelling of the injected limb, involving an increase in limb circumference, and sometimes involving the entire injected thigh or upper arm, have been reported with INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) .14,19,20 These reactions have generally begun within 48 hours of vaccination and resolved over an average of 4 days (range 1 to 10 days) without sequelae.14 In the German study in which 5,361 children received a fourth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) after 3 doses of the same vaccine, swelling of the injected thigh was reported spontaneously in 62 vaccinees (1.2%).14 This swelling was associated with pain upon digital pressure in 53% of cases, with rectal temperature ≥ 100.4°F in 45% of cases, and with injection site redness in 71% of cases (redness of the entire thigh was reported in 17% of such cases). The mean difference in the circumference of the thighs in those subjects in whom this was measured (N = 17) was 2.2 cm (range: 0.5 to 5 cm). In 1,809 children for whom standardized diaries were available, extensive limb swelling was observed in 2.5% of vaccinees. In the two German studies in which subjects received a fifth consecutive dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) , the vaccine was administered in the deltoid muscle in most subjects, and in the thigh in a minority of subjects. In Study A, in which 93 children received a fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) after 4 doses of the same vaccine, extensive swelling of the injected limb was reported spontaneously in 9 vaccinees (9.7%). This swelling was associated with pain and redness in all cases, and with fever in one case. The mean increase in the circumference of the injected limb compared with the opposite limb in those subjects in whom this was measured (N = 8) was 4.4 cm (range: 2 to 7 cm). In 3 cases, the investigators provided additional descriptive information - one case was described as involving the chest, and 2 cases were noted to involve the entire upper arm from the shoulder to the elbow. In Study B, in which 390 children received a fifth dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) after 4 doses of the same vaccine, extensive swelling of the injected limb was reported spontaneously in 25 vaccinees (6.4%). This swelling was associated with redness in all cases, with pain in 88%, and with fever in 12%. The mean increase in the circumference of the injected limb compared with the opposite limb in those subjects in whom this was measured (N = 22) was 3.8 cm (range: 1.2 to 16 cm).14

In postmarketing reports, extensive limb swelling also has been reported following administration of each of the first 3 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) (see ADVERSE REACTIONS, Postmarketing Reports). Extensive limb swelling has also been reported following administration of other acellular DTP vaccines,20,21 acellular pertussis vaccine alone (without DT),22 whole-cell DTP vaccine,23 and other vaccines.24

Table 6 lists the frequency of adverse events in US children who received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) (N = 110) or US-licensed whole-cell DTP vaccine (N = 55) manufactured by Lederle Laboratories at 15 to 20 months of age25 and in US children who received INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) (N = 115) or US-licensed whole-cell DTP vaccine (N = 57) manufactured by Lederle Laboratories at 4 to 6 years of age.26 All children had previously received 3 or 4 doses of whole-cell DTP vaccine at approximately 2, 4, 6, and 15-18 months of age. Adverse events were actively solicited using standardized diaries with follow-up telephone calls made at days 1, 4, and 8 by blinded study personnel. Significantly fewer solicited local and general adverse events were reported following INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) than following whole-cell DTP vaccine when administered as the fourth or fifth dose in those previously primed with 3 or 4 doses of whole-cell DTP vaccine.

Table 6.25,26 Adverse Events (%) Occurring Within the 3 Days Following Vaccination With INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) Administered at 15 to 20 Months and 4 to 6 Years of Age in US Children Who Had Previously Received 3 or 4 Doses of Whole-Cell DTP Vaccine

Event 15 to 20 months
3 Previous Doses of Whole-Cell DTP Vaccine
4 to 6 years
4 Previous Doses of Whole-Cell DTP Vaccine
INFANRIX
(N = 110)
Whole-Cell DTP Vaccine
(N = 55)
INFANRIX
(N = 115)
Whole-Cell DTP Vaccine
(N = 57)
Local
  Redness* 23 45 19 40
  Redness > 10 mm 5 31 7 26
  Swelling 14 24 15* 33*
  Swelling > 10 mm 7 15 8 18
  Pain†§ 5 38 12 40
Systemic
  Fever* ( ≥ 99.4°F) 25 42 23 47
  Fever ( > 100.5° F) 2 20 1 12
  Fussiness 34 69 20 30
  Drowsiness 9* 24* 11 18
  Poor Appetite* 9 20 6 16
  Vomiting 2 0 1 4
* p < 0.05.
p < 0.0001.
Oral temperatures.
§ Moderate or severe = cried or protested to touch or cried when arm moved.

Severe adverse events reported from the double-blind, randomized comparative Italian study involving 4,696 children administered INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) or 4,678 children administered whole-cell DTP vaccine (manufactured by Connaught Laboratories, Inc.) as a 3-dose primary series are shown in Table 7. The incidence of rectal temperature ≥ 104°F, hypotonic-hyporesponsive episodes and persistent crying ≥ 3 hours following administration of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) was significantly less than that following administration of whole-cell DTP vaccine.6 Hospitalization rates and death rates within 7 days of vaccination were similar between INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and DT vaccine recipients.14

 

Table 7.6 Severe Adverse Events Occurring Within 48 Hours Following Vaccination With INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) or Whole-Cell DTP in Italian Infants at 2, 4, or 6 Months of Age

Event INFANRIX
(N = 13,761 Doses)
Whole-Cell DTP Vaccine
(N = 13,520 Doses)
Number Rate/1,000 Doses Number Rate/1,000 Doses
Fever ( ≥ 104°F)* 5 0.36 32 2.4
Hypotonic-hyporesponsive episode 0 0 9 0.67
Persistent crying ≥ 3 hours* 6 0.44 54 4.0
Seizures** 1§ 0.07 3 0.22
* p < 0.001.
Rectal temperatures.
p = 0.002.
§ Maximum rectal temperature within 72 hours of vaccination = 103.1°F.
Maximum rectal temperature within 72 hours of vaccination = 99.5°F, 101.3°F, and 102.2°F.
** Not statistically significant at p < 0.05.

In the German safety study that enrolled 22,505 infants (66,867 doses of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) administered as a 3-dose primary series), all subjects were monitored for unsolicited adverse events that occurred within 28 days following vaccination using report cards. In a subset of subjects (N = 2,457), these cards were standardized diaries which solicited specific adverse events that occurred within 8 days of each vaccination in addition to unsolicited adverse events which occurred throughout the course of the entire trial (from study enrollment until approximately 30 days following the third vaccination). Cards from the whole cohort were returned at subsequent visits and were supplemented by spontaneous reporting by parents and a medical history after the first and second doses of vaccine. In the subset of 2,457, adverse events following the third dose of vaccine were reported via standardized diaries and spontaneous reporting at a follow-up visit. Adverse events in the remainder of the cohort were reported via report cards which were returned by mail approximately 28 days after the third dose of vaccine. Adverse events (rates per 1,000 doses) occurring within 7 days following any of the first 3 doses included: unusual crying (0.09), febrile seizure (0.0), afebrile seizure (0.13), and hypotonic-hyporesponsive episodes (0.01).

Rates of serious adverse events that are less common than those reported in this safety study are not known at this time.

In an ongoing US coadministration safety study, INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) was administered concomitantly at separate sites with 7-valent pneumococcal and Hib conjugate vaccines (Lederle Laboratories), Hepatitis B Vaccine (Recombinant) (GlaxoSmithKline Biologicals), and inactivated poliovirus vaccine (IPV) (Sanofi Pasteur SA) at 2, 4, and 6 months of age. Following dose 1 at 2 months of age, fever ≥ 100.4°F, > 101.3°F, > 102.2°F, and > 103.1°F occurring within 4 days (i.e., day of vaccination and the next 3 days) was reported in 19.8%, 4.5%, 0.3%, and 0.0%, respectively, of infants (N = 333). The frequency of irritability/fussiness, drowsiness, and loss of appetite was 61.5%, 54%, and 27.8%, respectively.

In clinical trials involving more than 29,000 infants and children, 14 deaths in INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) recipients were reported. Causes of deaths included 9 cases of Sudden Infant Death Syndrome (SIDS) and one of each of the following: meal aspiration, hepatoblastoma, neuroblastoma, invasive bacterial infection, and sudden death in a child older than 1 year of age. None of these events was determined to be vaccine-related. The rate of SIDS observed in the German safety study that enrolled 22,505 infants was 0.3/1,000 vaccinated infants. The rate of SIDS in the Italian efficacy trial was 0.4/1,000 infants vaccinated with INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) . The reported rate of SIDS in the United States from 1990 to 1994 was 1.2/1,000 live births.27 By chance alone, some cases of SIDS can be expected to follow receipt of pertussis-containing vaccines.13

As with any vaccine, there is the possibility that broad use of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) could reveal adverse events not observed in clinical trials.

Additional Adverse Reactions: Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) has been reported after receiving preparations containing diphtheria, tetanus, and/or pertussis antigens.13 Arthus-type hypersensitivity reactions, characterized by severe local reactions, may follow receipt of tetanus toxoid. A review by the IOM found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré Syndrome.28 A few cases of demyelinating diseases of the CNS have been reported following some tetanus toxoid-containing vaccines or tetanus and diphtheria toxoid-containing vaccines, although the IOM concluded that the evidence was inadequate to accept or reject a causal relationship.28 A few cases of peripheral mononeuropathy and of cranial mononeuropathy have been reported following tetanus toxoid administration, although the IOM concluded that the evidence was inadequate to accept or reject a causal relationship.

Postmarketing Reports: Worldwide voluntary reports of adverse events received for INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) since market introduction are listed below. This list includes adverse events for which 20 or more reports were received with the exception of intussusception, idiopathic thrombocytopenic purpura, thrombocytopenia, anaphylactic reaction, encephalopathy, and hypotonic-hyporesponsive episode for which fewer than 20 reports were received. These latter events are included either because of the seriousness of the event or the strength of causal connection to components of this or other vaccines or drugs.

Body as a Whole: Fever, Sudden Infant Death Syndrome.

Cardiovascular System: Cyanosis.

Gastrointestinal System: Diarrhea, intussusception, vomiting.

Hematologic/lymphatic: Idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia.

Hypersensitivity: Anaphylactic reaction, hypersensitivity.

Infections: Cellulitis.

Injection Site Reactions: Injection site reactions.

Musculoskeletal: Limb swelling.

Nervous System: Convulsions, encephalopathy, hypotonia, hypotonic-hyporesponsive episode, somnolence.

Psychiatric: Crying, irritability.

Respiratory System: Respiratory tract infection.

Skin and Appendages: Erythema, pruritus, rash, urticaria.

Special Senses:Ear pain.

These adverse events were reported voluntarily from a population of uncertain size; therefore, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.

Reporting Adverse Events: The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient's permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.29 The Act further requires the healthcare provider to report to the US Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 7 days, encephalopathy or encephalitis within 7 days, brachial neuritis within 28 days, or an acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this prescribing information.29,30 These events should be reported to VAERS. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov.

Read the entire FDA prescribing information for Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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