SAFETY

The established safety profile of PEDIARIX

The safety profile of PEDIARIX was established in 14 clinical trials worldwide.1

23,849 doses

of PEDIARIX

23,849 doses of PEDIARIX administered to 8088 infants who received 1 or more doses

administered to
8088 infants
who received 1 or more doses

Common solicited adverse reactions following any dose (≥25%) included local injection site reactions (pain, redness, and swelling), fever (≥100.4°F), drowsiness, irritability/fussiness, and loss of appetite.1

 

The safety profile of PEDIARIX was demonstrated in clinical trials and reinforced
in a postmarketing safety surveillance study1

 

Data From a US Safety Study: Percentage of Infants With
Solicited Local and General
Adverse Reactions Within 4 Days
of Vaccinationa at 2, 4, and 6
Months of Age (Modified Intent-to-Treat Cohort)1

Adverse Reactions

  Dose 1 Dose 2 Dose 3
  PEDIARIX, Hib Vaccine, & PCV7

INFANRIX, ENGERIX-B, IPV,

Hib Vaccine,  & PCV7

 PEDIARIX, Hib Vaccine, & PCV7

INFANRIX, ENGERIX-B, IPV,

Hib Vaccine,  & PCV7

 PEDIARIX, Hib Vaccine, & PCV7

INFANRIX, ENGERIX-B, IPV,

Hib Vaccine,  & PCV7
Localb
n 671 335 653 323 648 315

Pain, any

Pain, Grade 2 or 3

Pain, Grade 3

36

12

2

32

9

3

36

11

3

30

9

2

31

11

2

30

9

1

Redness, any

Redness, >5 mm

Redness, >20 mm

25c

6c

1

18

2

0

37

10c

1c

33

6

0

40

13c

3

39

7

2

Swelling, any

Swelling, >5 mm

Swelling, >20 mm

17c

6c

2

10

2

1

27c

10c

3c

20

5

0

29

9c

3

25

4

1
General
n 667 333 644 321 645 311

Feverd , ≥100.4°F

Feverd , >101.3°F

Feverd , >102.2°F

Feverd , >103.1°F

Feverd , M.A.

28c

7

2c

1

1c

20

5

0

0

0

39c

14

4

1

0

30

10

3

0

1

34c

9

3

1

1

24

6

2

0

0
n 671 335 653 323 648 315

Drowsiness, any

Drowsiness, Grade 2 or 3

Drowsiness, Grade 3

57

16

3

54

18

4

52

14

1

48

12

1

41

11

1

38

11

2

Irritability/Fussiness, any

Irritability/Fussiness, Grade 2 or 3

Irritability/Fussiness, Grade 3

61

20

3

62

19

4

65

28c

4

62

21

3

61

25c

4

57

19

3

Loss of Appetite, any

Loss of Appetite, Grade 2 or 3

Loss of Appetite, Grade 3

30

7

1

28

5

1

31

8c

0

27

3

0

26

6

0

24

5

0

Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.; no longer licensed in the United States); PCV7 (Wyeth Pharmaceuticals Inc.); IPV (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 1 symptom sheet was completed; for fever, numbers excludes missing temperature recordings or tympanic measurements.

M.A.=medically attended (a visit to or from medical personnel).

Grade 2 defined as sufficiently discomforting to interfere with daily activities.

Grade 3 defined as preventing normal daily activities.

a Within 4 days of vaccination defined as day of vaccination and the next 3 days.

b Local reactions at the injection site for PEDIARIX or INFANRIX.

c Rate significantly higher in the group that received PEDIARIX compared with separately administered vaccines (P value <0.05 [2-sided Fisher Exact test] or the 95% CI on the difference between groups [Separate minus PEDIARIX] does not include 0).

d Axillary temperatures increased by 1°C and oral temperatures increased by 0.5°C to derive equivalent rectal temperature.

 

In a safety surveillance study conducted at a health maintenance organization in the
United States, infants who received 1 or
more doses of PEDIARIX from mid-2003
through mid-2005 were compared with matched historical controls who received 1 or more doses of separately administered US-licensed DTaP vaccine from 2002 through mid-2003. Meaningful differences with regard to verified seizures and medically attended fever were not observed.1

CI=confidence interval; DTaP=diphtheria, tetanus, and acellular pertussis.