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More than 7,000 infants and young children ( ≤ 2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions.

Adverse reactions commonly associated with a first ActHIB vaccine immunization of children 12 to 15 months of age who were previously unimmunized with any Haemophilus b conjugate vaccine, include local pain, redness, and swelling at the injection site. Systemic reactions include fever, irritability, and lethargy.4,10

Adverse reactions associated with ActHIB vaccine generally subsided after 24 hours and usually do not persist beyond 48 hours after immunization.

In a US trial, safety of TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, in 110 children aged 15 to 20 months was compared to ActHIB vaccine given with Tripedia vaccine at separate sites to 110 children. All children received three doses of Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age.

Table 5: Local and Systemic Reactions at 6, 24, and 48 Hours Following Immunization with ActHIB and Tripedia Vaccines Given Concomitantly at Separate Sites Compared to TriHIBita Vaccine in Children 15- to 20-months-old10

Adverse Event 6 Hrs. Post-dose 24 Hrs. Post-dose 48 Hrs. Post-dose
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Separate Injectionsb
N = 110
TriHIBit vaccine
N = 110
Local (%)
Tenderness 17.3/20.0 19.1 8.2/8.2 10.0 1.8/0.9 1.8
Erythema > 1” 0.9/0.0 3.6 2.7/0.9 3.6 0.9/0.0 1.8
Indurationc 3.6/5.5 2.7 2.7/3.6 8.2 4.5/0.9 3.6
Swelling 3.6/3.6 3.6 2.7/1.8 5.5 0.9/0.0 4.5
Systemic (%) N = 103-110 N = 102-109 N = 105-110 N = 103-108 N = 104-110 N = 103-109
Fever > 102.2°F (39.0°C) 0 2.0 1.0 1.9 1.9 0
Irritability 27.3 22.9 20.9 17.6 12.7 10.1
Drowsiness 36.4 30.3 17.3 13.9 12.7 11.0
Anorexia 12.7 9.2 10.0 6.5 6.4 2.8
Vomiting 0.9 1.8 0.9 1.9 0.9 2.8
Persistent Cry 0 0 0 0 0 0
Unusual Cry 0 0 0 0 0 0.9
a TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution
b Tripedia vaccine injection site/ActHIB vaccine injection site
c Induration is defined as hardness with or without swelling

TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was administered to approximately 850 children, aged 15 to 20 months. All children received three doses of a Haemophilus b conjugate vaccine (ActHIB vaccine or HibTITER) and three doses of whole-cell DTP at approximately 2, 4, and 6 months of age. Local reactions were typically mild and usually resolved within the 24 to 48 hour period after immunization. The most common local reactions were pain and tenderness at the injection site. Systemic reactions occurring were usually mild and resolved within 72 hours of immunization. The reaction rates were similar to those observed in TABLE 5 when TriHIBit vaccine, ActHIB vaccine reconstituted with Tripedia vaccine, was administered and when Tripedia vaccine was administered alone as a booster.10

The number of subjects studied with TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, was inadequate to detect rare serious adverse events.

Reporting of Adverse Events

Reporting by the parent or guardian 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 1-800-822-7967.15,16,18

Health-care providers also should report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of ActHIB. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

  • Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
  • Nervous System Disorders: Convulsions
  • General Disorders and Administration Site Conditions: Extensive limb swelling, peripheral edema, pruritus, and rash