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

Adverse reactions commonly associated with a first ActHIB^® 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. ^14,18

In a multicenter trial, ActHIB^® was administered to US infants at 2, 4, and 6 months of age concomitantly, at separate sites, with AvP D.P. The adverse events observed are summarized in Table 5.

^§ Local reactions were evaluated at the ActHIB^® injection site.

* The adverse reaction profile is defined by the concomitant use of AvP DTP vaccine.

^† The number of individuals observed at each time point for fever varied from 357 to 363.

In general, the rates of minor systemic reactions after ActHIB^® and DTP immunization were comparable to those usually reported after DTP vaccine alone. ^30,31,32,33

When ActHIB^® reconstituted with AvP whole-cell DTP was administered in infants at 2, 4, and 6 months of age, the systemic adverse experience profile (Table 6) was comparable to that observed when the two vaccines were given separately (Table 5). An increase in the rates of local reactions was observed within the 24- hour period after immunization. ¹⁸

In a third US trial when ActHIB^® was combined with DTP by reconstitution, approximately 1,450 doses were administered to infants starting at 2 months of age. Adverse reactions observed at 6 and 24 hours respectively after the first immunization (n=498) were tenderness 66.9% and 30.7%; erythema (>1") 8.6% and 2.2%; induration 38.2% and 21.7%; irritability 77.9% and 35.7%; drowsiness 63.7% and 34.1%; anorexia 26.1% and 12.9%; diarrhea 6.8% and 9.0%; and vomiting 3.4% and 3.8%. ¹⁸ One hypotonic hyporesponsive episode (HHE) was seen in an infant following the second dose in this trial. This is consistent with the HHE incidence rate observed with DTP vaccination alone. ⁴

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

No data are available on the safety of a booster dose of ActHIB^® combined with AvP DTP vaccine by reconstitution given in 15 to 20 month old children.

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

* Tripedia injection site ActHIB^® injection site.

** Induration is defined as hardness with or without swelling.

TriHIBit^® ActHIB^® combined with Tripedia^® 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^® 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 7 when TriHIBit^® ,ActHIB^® reconstituted with Tripedia^® was administered and when Tripedia^® was administered alone as a booster. ¹⁸

In a randomized, double-blind US clinical trial, ActHIB^® was given concomitantly with DTP to more than 5,000 infants and hepatitis B vaccine was given with DTP to a similar number. In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed but were not different in the two groups. In the first 48 hours following immunization, two definite and three possible seizures were observed after ActHIB and DTP in comparison with none after hepatitis B vaccine and DTP 18 This rate of seizures following ActHIB^® and DTP was not greater than previously reported in infants receiving DTP alone. (Refer to product insert for AvP DTP.) Other adverse reactions reported with administration of other Haemophilus b conjugate vaccines include urticaria, seizures, hives, renal failure and Guillain-Barré syndrome (GBS). ^18,34 A cause and effect relationship among any of these events and the vaccination has not been established.

When ActHIB^® was given with DTP and inactivated poliovirus vaccine to more than 100,000 Finnish infants, the rate and extent of serious adverse reactions were not different from those seen when other Haemophilus b conjugate vaccines were evaluated in Finland (i.e. HibTITER^®,ProHIBiT^®)¹⁸

However, the number of subjects studied with TriHIBit^®,ActHIB^® combined with Tripedia^® 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 toll-free number 1-800-822-7967. ^26,27,28

Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.

When AvP DTP is used to reconstitute ActHIB^® or Tripedia^® is used to reconstitute ActHIB^® (TriHIBit^® )and administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody response may not be obtained.

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Although no specific studies with pertussis vaccine are available, if immunosuppressive therapy will be discontinued shortly, it is reasonable to defer vaccination until the patient has been off therapy for one month; otherwise, the patient should be vaccinated while still on therapy. ²³

If ActHIB^® reconstituted with AvP DTP or ActHIB^® reconstituted with Tripedia^® (TriHIBit^® ) has been administered to persons receiving immunosuppressive therapy, a recent injection of immunoglobulin or having an immunodeficiency disorder, an adequate immunologic response may not be obtained.

In clinical trials, ActHIB^® was administered, at separate sites, concomitantly with one or more of the following vaccines: D.P. DTaP, Poliovirus Vaccine Live Oral (OPV), Measles, Mumps and Rubella vaccine (MMR), Hepatitis B vaccine and occasionally Inactivated Poliovirus Vaccine (IPV). No impairment of the antibody response to the individual antigens, diphtheria, tetanus and pertussis was demonstrated when ActHIB^® was given at the same time, at separate sites, with IPV or MMR. ¹⁸ In addition, more than 47,000 infants in Finland have received a third dose of ActHIB^® concomitantly with MMR vaccine with no increase in serious or unexpected adverse events. ¹⁸

No significant impairment of antibody response to Measles, Mumps and Rubella was noted in 15 - 20 month-old children who received TriHIBit^® , ActHIB^® reconstituted with Tripedia^® concomitantly with MMR. No data are available to the manufacturer concerning the effects on immune response of OPV, IPV or Hepatitis B vaccine when given concurrently with ActHIB^® reconstituted with 0.4% Sodium Chloride or AvP DTP or ActHIB^® reconstituted with Tripedia^® TriHIBit ^®.¹⁸

As with other intramuscular injections, use with caution in patients on anticoagulant therapy.

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