Vaccine Information: INFANRIX

INFANRIX- clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) and bordetella pertussis pertactin antigen (formaldehyde inactivated) suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday).

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule

A 0.5-mL dose of INFANRIX is approved for intramuscular administration in infants and children aged 6 weeks through 6 years (prior to the 7th birthday) 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 (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The first dose may be given as early as 6 weeks of age.

The preferred administration site is the anterolateral aspect of the thigh for most infants aged younger than 12 months and the deltoid muscle of the upper arm for most children aged 12 months through 6 years.

2.3 Use of INFANRIX with Other DTaP Vaccines

Sufficient data are not available on the safety and effectiveness of interchanging INFANRIX and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers for successive doses of the DTaP vaccination series. Because the pertussis antigen components of INFANRIX and PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] are the same, INFANRIX may be used to complete a DTaP vaccination series initiated with PEDIARIX.

2.4 Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given [see Contraindications (4.2, 4.3), Warnings and Precautions (5.5)], Diphtheria and Tetanus Toxoids Adsorbed (DT) For Pediatric Use should be given according to its prescribing information.

3 DOSAGE FORMS AND STRENGTHS

INFANRIX is a suspension for injection available in 0.5-mL single-dose vials and 0.5-mL single-dose, prefilled TIP‑LOK syringes.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX is a contraindication [see Description (11)]. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered.

4.2 Encephalopathy

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX.

4.3 Progressive Neurologic Disorder

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome

If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including INFANRIX, should be based on careful consideration of the potential benefits and possible risks. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated.

5.2 Latex

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.3 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including INFANRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

5.4 Adverse Reactions following Prior Pertussis Vaccination

If any of the following reactions occur in temporal relation to receipt of a pertussis-containing vaccine, the decision to give any pertussis-containing vaccine, including INFANRIX, should be based on careful consideration of the potential benefits and possible risks:

Temperature of ≥40.5o C (105o F) within 48 hours not due to another identifiable cause;
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours;
Seizures with or without fever occurring within 3 days.

5.5 Children at Risk for Seizures

For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a pertussis-containing vaccine, including INFANRIX, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

5.6 Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including INFANRIX, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

5.7 Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Approximately 95,000 doses of INFANRIX have been administered in clinical studies. In these studies, 29,243 infants have received INFANRIX in primary series studies: 6,081 children have received a fourth consecutive dose of INFANRIX, 1,764 children have received a fifth consecutive dose of INFANRIX, and 559 children have received a dose of INFANRIX following 3 doses of PEDIARIX.

Solicited Adverse Reactions

In a U.S. study, 335 infants received INFANRIX, ENGERIX-B [Hepatitis B Vaccine (Recombinant)], inactivated poliovirus vaccine (IPV, Sanofi Pasteur SA), Haemophilus b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.), and pneumococcal 7-valent conjugate (PCV7) vaccine (Wyeth Pharmaceuticals Inc.) concomitantly at separate sites. All vaccines were administered at 2, 4, and 6 months of age. Data on solicited local reactions and general adverse reactions were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) (Table 1). Among subjects, 69% were white, 16% were Hispanic, 8% were black, 4% were Asian, and 2% were of other racial/ethnic groups.

Table 1. Solicited Local and General Adverse Reactions (%) Occurring within 4 Days of Vaccinationa with Separate Concomitant Administration of INFANRIX, ENGERIX-B, IPV, Haemophilus b (Hib) Conjugate Vaccine, and Pneumococcal Conjugate Vaccine (PCV7) (Modified Intent-to-Treat Cohort)
Hib conjugate vaccine and PCV7 manufactured by Wyeth Pharmaceuticals Inc. IPV manufactured by Sanofi Pasteur SA.Modified intent-to-treat cohort = All vaccinated subjects for whom safety data were available.n = Number of infants for whom at least one symptom sheet was completed; for fever; numbers exclude missing temperature recordings or tympanic measurements.Grade 2: Pain defined as cried/protested on touch; drowsiness defined as interfered with normal daily activities; irritability/fussiness defined as crying more than usual/interfered with normal daily activities; loss of appetite defined as eating less than usual/interfered with normal daily activities.Grade 3: Pain defined as cried when limb was moved/spontaneously painful; drowsiness defined as prevented normal daily activities; irritability/fussiness defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as no eating at all.a Within 4 days of vaccination defined as day of vaccination and the next 3 days.b Local reactions at the injection site for INFANRIX.c Axillary temperatures increased by 1°C and oral temperatures increased by 0.5°C to derive equivalent rectal temperature.

Adverse Reaction

INFANRIX, ENGERIX-B, IPV, Hib Vaccine, & PCV7

Dose 1

Dose 2

Dose 3

Localb

n

335

323

315

Pain, any

32

30

30

Pain, Grade 2 or 3

9

9

9

Pain, Grade 3

3

2

1

Redness, any

18

33

39

Redness, >20 mm

0

0

2

Swelling, any

10

20

25

Swelling, >20 mm

1

0

1

General

n

333

321

311

Feverc (≥100.4°F)

20

30

24

Feverc (>101.3°F)

5

8

6

Feverc (>102.2°F)

0

3

2

Feverc (>103.1°F)

0

0

0

n

335

323

315

Drowsiness, any

54

48

38

Drowsiness, Grade 2 or 3

18

12

11

Drowsiness, Grade 3

4

1

2

Irritability/Fussiness, any

62

62

57

Irritability/Fussiness, Grade 2 or 3

19

21

19

Irritability/Fussiness, Grade 3

4

3

3

Loss of appetite, any

28

27

24

Loss of appetite, Grade 2 or 3

5

3

5

Loss of appetite, Grade 3

1

0

0

In a U.S. study, the safety of a booster dose of INFANRIX was evaluated in children aged 15 to 18 months whose previous 3 DTaP doses were with INFANRIX (n = 251) or PEDIARIX (n = 559). Vaccines administered concurrently with the fourth dose of INFANRIX included measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.), varicella vaccine (Merck & Co., Inc.), pneumococcal 7-valent conjugate (PCV7) vaccine (Wyeth Pharmaceuticals Inc.), and any U.S.-licensed Hib conjugate vaccine; these were given concomitantly in 13.2%, 6.3%, 37.4%, and 41.2% of subjects, respectively. Data on solicited adverse reactions were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) (Table 2). Among subjects, 85% were white, 6% were Hispanic, 6% were black, 1% were Asian, and 2% were of other racial/ethnic groups.

Table 2. Solicited Local and General Adverse Reactions (%) Occurring within 4 Days of Vaccinationa with INFANRIX Administered as the Fourth Dose following 3 Previous Doses of INFANRIX or PEDIARIX (Total Vaccinated Cohort)
Total Vaccinated Cohort = All subjects who received a dose of study vaccine.n = Number of subjects for whom at least one symptom sheet was completed.Grade 2: Pain defined as cried/protested on touch; drowsiness defined as interfered with normal daily activities; irritability defined as crying more than usual/interfered with normal daily activities; loss of appetite defined as eating less than usual/no effect on normal daily activities.Grade 3: Pain defined as cried when limb was moved/spontaneously painful; drowsiness defined as prevented normal daily activities; irritability defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as eating less than usual/interfered with normal daily activities.a Within 4 days of vaccination defined as day of vaccination and the next 3 days.b Received INFANRIX, ENGERIX-B, IPV (Sanofi Pasteur SA), PCV7 vaccine (Wyeth Pharmaceuticals Inc.), and Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age.c Received PEDIARIX, PCV7 vaccine (Wyeth Pharmaceuticals Inc.), and Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age or PCV7 vaccine 2 weeks later.d Local reactions at the injection site for INFANRIX.e Axillary temperatures.

Adverse Reaction

Group Primed with INFANRIXb

n = 247

Group Primed with PEDIARIXc

n = 553

Locald

Pain, any

45

48

Pain, Grade 2 or 3

19

19

Pain, Grade 3

4

3

Redness, any

48

50

Redness, >20 mm

6

6

Swelling, any

33

33

Swelling, >20 mm

4

5

Increase in mid-thigh circumference, any

33

26

Increase in mid-thigh circumference, >40 mm

0

1

General

Fevere (>99.5°F)

9

15

Fevere (>100.4°F)

5

7

Fevere (>101.3°F)

2

2

Drowsiness, any

36

31

Drowsiness, Grade 2 or 3

9

7

Drowsiness, Grade 3

2

1

Irritability, any

52

54

Irritability, Grade 2 or 3

18

20

Irritability, Grade 3

3

1

Loss of appetite, any

25

23

Loss of appetite, Grade 2 or 3

5

5

Loss of appetite, Grade 3

2

0

In a U.S. study, the safety of a fifth consecutive dose of INFANRIX coadministered at separate sites with a fourth dose of IPV (Sanofi Pasteur SA) and a second dose of MMR vaccine (Merck & Co., Inc.) was evaluated in 1,053 children aged 4 to 6 years. Data on solicited adverse reactions were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (i.e., day of vaccination and the next 3 days) (Table 3). Among subjects, 43% were white, 18% Hispanic, 15% Asian, 7% black, and 17% were of other racial/ethnic groups.

Table 3. Solicited Local and General Adverse Reactions (%) Occurring within 4 Days of Vaccinationa with a Fifth Consecutive Dose of INFANRIX when Coadministered with IPV and MMR Vaccine (Total Vaccinated Cohort)
IPV manufactured by Sanofi Pasteur SA. MMR vaccine manufactured by Merck & Co., Inc.Total Vaccinated Cohort = All vaccinated subjects for whom safety data were available.n = Number of children with evaluable data for the reactions listed.a Within 4 days of vaccination defined as day of vaccination and the next 3 days.b Local reactions at the injection site for INFANRIX.c Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.d Grade 3 defined as preventing normal daily activities.e Grade 3 defined as not eating at all.

Localb

n = 1,039-1,043

Pain, any

53

Pain, Grade 2 or 3c

12

Pain, Grade 3c

1

Redness, any

37

Redness, ≥50 mm

20

Redness, ≥110 mm

4

Arm circumference increase, any

38

Arm circumference increase, >20 mm

7

Arm circumference increase, >30 mm

3

Swelling, any

27

Swelling, ≥50 mm

12

Swelling, ≥110 mm

2

General

n = 993-1,036

Drowsiness, any

18

Drowsiness, Grade 3d

1

Fever, ≥99.5°F

15

Fever, >100.4°F

4

Fever, >102.2°F

1

Fever, >104°F

0

Loss of appetite, any

16

Loss of appetite, Grade 3e

1

In the U.S. booster immunization studies in which INFANRIX was administered as the fourth or fifth dose in the DTaP series following previous doses with INFANRIX or PEDIARIX, large swelling reactions of the limb injected with INFANRIX were assessed.

In the fourth-dose study, a large swelling reaction was defined as injection site swelling with a diameter of >50 mm, a >50 mm increase in the mid-thigh circumference compared with the pre-vaccination measurement, and/or any diffuse swelling that interfered with or prevented daily activities. The overall incidence of large swelling reactions occurring within 4 days (Day 0-Day 3) following INFANRIX was 2.3%.

In the fifth-dose study, a large swelling reaction was defined as swelling that involved >50% of the injected upper arm length and that was associated with a >30 mm increase in mid-upper arm circumference within 4 days following vaccination. The incidence of large swelling reactions following the fifth consecutive dose of INFANRIX was 1.0%.

Less Common and Serious General Adverse Reactions

Selected adverse reactions reported from a double-blind, randomized Italian clinical efficacy trial involving 4,696 children administered INFANRIX or 4,678 children administered whole-cell DTP vaccine (DTwP) (manufactured by Connaught Laboratories, Inc.) as a 3-dose primary series are shown in Table 4. The incidence of rectal temperature ≥104°F, hypotonic-hyporesponsive episodes, and persistent crying ≥3 hours following administration of INFANRIX was significantly less than that following administration of whole-cell DTP vaccine.

Table 4. Selected Adverse Reactions Occurring within 48 Hours following Vaccination with INFANRIX or Whole-Cell DTP in Italian Infants at 2, 4, or 6 Months of Age
a P <0.001.b Rectal temperatures.c P = 0.002.d Not statistically significant at P <0.05.e Maximum rectal temperature within 72 hours of vaccination = 103.1°F.f Maximum rectal temperature within 72 hours of vaccination = 99.5°F, 101.3°F, and 102.2°F.

Reaction

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)a,b

5

0.36

32

2.4

Hypotonic-hyporesponsive episodec

0

0

9

0.67

Persistent crying ≥3 hoursa

6

0.44

54

4.0

Seizuresd

1e

0.07

3f

0.22

In a German safety study that enrolled 22,505 infants (66,867 doses of INFANRIX administered as a 3-dose primary series at 3, 4, and 5 months of age), 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 reactions that occurred within 8 days of each vaccination in addition to unsolicited adverse events which occurred from 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 reactions (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).

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