Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX

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  • Because clinical trials are conducted under widely varying conditions, adverse reaction 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. There is the possibility that broad use of INFANRIX could reveal adverse reactions not observed in clinical trials
  • 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
  • 559 children have received a dose of INFANRIX following 3 doses of PEDIARIX

Adverse Reactions With Concomitant Use of INFANRIX in a US Study "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[2]

  • In a US study, 335 infants received the following vaccines concomitantly at separate sites:
  • INFANRIX
  • ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]
  • Inactivated poliovirus vaccine (IPV, Sanofi Pasteur SA)
  • Haemophilus influenzae type b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.)
  • Pneumococcal 7-valent conjugate (PCV7) vaccine (Wyeth Pharmaceuticals Inc.; no longer available in the US)
  • All vaccines were administered at 2, 4, and 6 months of age
  • Data on solicited local reactions and general adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (day of vaccination and the next 3 days)
Solicited Locala Adverse Reactions (%) in Infants 2, 4, and 6 Months of Age Within 4 Days of Vaccinationb With Separate Concomitant Administration of INFANRIX, ENGERIX-B, IPV, Hib Conjugate Vaccine, and PCV7 (Modified ITT) [2]
  INFANRIX, ENGERIX-B, IPV, Hib Vaccine, & PCV7
  Dose 1
(N=335)
Dose 2
(N=323)
Dose 3
(N=315)
Pain, any 31.9 30.0 29.8
Pain, grade 2 or 3 9.0 8.7 8.9
Pain, grade 3 2.7 1.5 1.3
Redness, any 18.2 32.8 39.0
Redness, >20 mm 0.3 0.0 1.9
Swelling, any 9.6 20.4 24.8
Swelling, >20 mm 0.6 0.0 1.3

Haemophilus influenzae type b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.); pneumococcal 7-valent conjugate vaccine (PCV7; Wyeth Pharmaceuticals Inc.; no longer available in the US); inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA).
Modified intent to treat (ITT) cohort=all vaccinated subjects for whom safety data were available.
N=number of infants for whom at least one symptom sheet was completed.
Grade 2: pain defined as cried/protested on touch.
Grade 3: pain defined as cried when limb was moved/spontaneously painful.

a Local reactions at the injection site for INFANRIX.
b Occurring within 4 days of vaccination (day of vaccination and next 3 days).
Solicited General Adverse Events (%) in Infants 2, 4, and 6 Months of Age Within 4 Days of Vaccinationa With Separate Concomitant Administration of INFANRIX, ENGERIX-B, IPV, Hib Conjugate Vaccine, and PCV7 (Modified ITT) [2]
  INFANRIX, ENGERIX-B, IPV, Hib Vaccine, & PCV7
  Dose 1
(N=333)
Dose 2
(N=321)
Dose 3
(N=311)
Feverb (≥100.4°F) 19.8 30.2 23.8
Feverb (>101.3°F) 4.5 9.7 5.8
Feverb (>102.2°F) 0.3 3.1 2.3
Feverb (>103.1°F) 0.0 0.3 0.3
  Dose 1
(N=335)
Dose 2
(N=323)
Dose 3
(N=315)
Drowsiness, any 54.0 48.3 38.4
Drowsiness, grade 2 or 3 17.6 12.4 11.1
Drowsiness, grade 3 3.6 0.6 1.9
Irritability/Fussiness, any 61.5 61.6 56.5
Irritability/Fussiness, grade 2 or 3 19.4 21.1 19.4
Irritability/Fussiness, grade 3 3.9 3.4 3.2
Loss of appetite, any 27.8 26.6 23.8
Loss of appetite, grade 2 or 3 5.1 3.4 5.4
Loss of appetite, grade 3 0.6 0.3 0.0

Haemophilus influenzae type b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.); pneumococcal 7-valent conjugate vaccine (PCV7; Wyeth Pharmaceuticals Inc.; no longer available in the US); inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA).
Modified intent to treat (ITT) 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: 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: 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 Occurring within 4 days of vaccination (day of vaccination and next 3 days).
b Axillary temperatures increased by 1°C and oral temperatures increased by 0.5°C to derive equivalent rectal temperature.

Adverse Reactions With a Fourth Dose of INFANRIX in a US Study "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[2]

  • In a US study, the safety of a booster dose of INFANRIX was evaluated in children 15 to 18 months of age 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 vaccine (PCV7; Wyeth Pharmaceuticals Inc.; no longer available in the US)
  • Any US-licensed Haemophilus influenzae type b (Hib) conjugate vaccine
  • Data on solicited adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (ie, day of vaccination and the next 3 days)
Solicited Locala Adverse Reactions (%) in Children 15 to 18 Months of Age Within 4 Days of Vaccinationb With INFANRIX Administered as the Fourth Dose Following 3 Previous Doses of INFANRIX or PEDIARIX (TVC) [2]
  Group Primed With INFANRIXc (N=247) Group Primed With PEDIARIXd (N=553)
Pain, any
Pain, grade 2 or 3
Pain, grade 3
44.5
19.0
3.6
48.3
18.6
3.4
Redness, any
Redness, >20 mm
48.2
6.1
49.9
6.0
Swelling, any
Swelling, >20 mm
32.8
3.6
32.7
5.2
Increase in mid-thigh circumference, any 33.2 26.2
Increase in mid-thigh circumference, >40 mm 0.0 1.3

N=number of subjects for whom at least one symptom sheet was completed.
Total vaccinated cohort (TVC)=all subjects who received a dose of study vaccine.
Grade 2: pain defined as cried/protested on touch.
Grade 3: pain defined as cried when limb was moved/spontaneously painful.

a Local reactions at the injection site for INFANRIX.
b Within 4 days of vaccination defined as day of vaccination and the next 3 days.
c Received INFANRIX, ENGERIX-B, inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA), pneumococcal 7-valent conjugate vaccine (PCV7; Wyeth Pharmaceuticals Inc.; no longer available in the US), and Haemophilus influenzae type b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age.
d Received PEDIARIX, PCV7 vaccine (Wyeth Pharmaceuticals Inc.; no longer available in the US), and Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age or PCV7 vaccine 2 weeks later.
  • 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 to 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%
Solicited General Adverse Events (%) in Children 15 to 18 Months of Age Within 4 Days of Vaccinationa With INFANRIX Administered as the Fourth Dose Following 3 Previous Doses of INFANRIX or PEDIARIX (TVC) [2]
  Group Primed With INFANRIXb (N=247) Group Primed With PEDIARIXc (N=553)
Feverd (>99.5°F)
Feverd (>100.4°F)
Feverd (>101.3°F)
8.9
4.5
2.0
15.4
6.7
2.0
Drowsiness, any
Drowsiness, grade 2 or 3
35.6
9.3
31.3
6.7
Drowsiness, grade 3 2.4 1.3
Irritability, any
Irritability, grade 2 or 3
Irritability, grade 3
52.2
18.2
3.2
53.9
19.7
1.4
Loss of appetite, any
Loss of appetite, grade 2 or 3
24.7
5.3
23.3
4.9
Loss of appetite, grade 3 2.4 0.5

N=number of subjects for whom at least one symptom sheet was completed. Total vaccinated cohort (TVC)=all subjects who received a dose of study vaccine.
Grade 2: 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: 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, inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA), pneumococcal 7-valent conjugate vaccine (PCV7; Wyeth Pharmaceuticals Inc.; no longer available in the US), and Haemophilus influenzae type b (Hib) conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age.
c Received PEDIARIX, PCV7 vaccine (Wyeth Pharmaceuticals Inc.; no longer available in the US), and Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age or PCV7 vaccine 2 weeks later.
d Axillary temperatures.

Adverse Reactions With a Fifth Consecutive Dose of INFANRIX in a US Study "scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"[2]

  • In a US study, the safety of a fifth consecutive dose of INFANRIX was evaluated in 1,053 children 4 to 6 years of age
  • Vaccines administered concurrently at separate sites with the fifth dose of INFANRIX included
  • A fourth dose of inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA)
  • A second dose of measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.)
  • Data on solicited adverse events were collected by parents using standardized diary cards for 4 consecutive days following each vaccine dose (ie, day of vaccination and the next 3 days)
Solicited Locala Adverse Reactions (%) in Children 4 to 6 Years of Age Within 4 Days of Vaccinationb With a Fifth Consecutive Dose of INFANRIX When Coadministered With IPV and MMR Vaccine (TVC) [2]
  N=1,039-1,043
Pain, any
Pain, grade 2 or 3
Pain, grade 3
53.3
12.0
0.6
Redness, any
Redness, ≥50 mm
Redness, ≥110 mm
36.6
20.0
4.1
Arm circumference increase, any 37.8
Arm circumference increase, >20 mm 7.4
Arm circumference increase, >30 mm 3.2
Swelling, any
Swelling, ≥50 mm
Swelling, ≥110 mm
27.0
11.5
1.8

Inactivated poliovirus vaccine (IPV) manufactured by Sanofi Pasteur SA. Measles, mumps, and rubella (MMR) vaccine manufactured by Merck & Co., Inc.
Total vaccinated cohort (TVC)=all vaccinated subjects for whom safety data were available.
N=number of children with evaluable data for the events listed.
Grade 2 defined as painful when the limb was moved.
Grade 3 defined as preventing normal daily activities.

a Local reactions at the injection site for INFANRIX.
b Within 4 days of vaccination defined as day of vaccination and next 3 days.
  • Incidence of large swelling reactions in the limb injected with INFANRIX was also assessed 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%
Solicited General Adverse Events (%) in Children 4 to 6 Years of Age Within 4 Days of Vaccinationa With a Fifth Consecutive Dose of INFANRIX When Coadministered With IPV and MMR Vaccine (TVC) [2]
  N=933-1,036
Drowsiness, any
Drowsiness, grade 3b
17.5
0.8
Feverb (≥99.5°F)
Feverb (>100.4°F)
Feverb (>102.2°F)
Feverb (>104°F)
14.8
4.4
1.1
0.0
Loss of appetite, any
Loss of appetite, grade 3c
16.0
0.6

Inactivated poliovirus vaccine (IPV; Sanofi Pasteur SA); measles, mumps, and rubella (MMR; Merck & Co., Inc.).
Total vaccinated cohort (TVC)=all vaccinated subjects for whom safety data were available.
N=number of children with evaluable data for the events listed.

a Within 4 days of vaccination defined as day of vaccination and next 3 days.
b Grade 3 defined as preventing normal daily activities.
c Grade 3 defined as not eating at all.

814572R0 January 2017