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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
|Adverse Event||6 Hrs. Post-dose||24 Hrs. Post-dose||48 Hrs. Post-dose|
N = 110
N = 110
N = 110
N = 110
N = 110
N = 110
|Erythema > 1”||0.9/0.0||3.6||2.7/0.9||3.6||0.9/0.0||1.8|
|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|
|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.
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
Read the ActHIB (haemophilus b conjugate vaccine) Side Effects Center for a complete guide to possible side effects
When Tripedia vaccine is used to reconstitute ActHIB vaccine (TriHIBit vaccine) 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.14
If ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine) 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 vaccine was administered, at separate sites, concomitantly with one or more of the following vaccines: DTP, 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 vaccine was given at the same time, at separate sites, with IPV or MMR.10 In addition, more than 47,000 infants in Finland have received a third dose of ActHIB vaccine concomitantly with MMR vaccine with no increase in serious or unexpected adverse events.10
No significant impairment of antibody response to Measles, Mumps and Rubella was noted in 15- to 20-month-old children who received TriHIBit vaccine, ActHIB vaccine reconstituted with Tripedia vaccine, 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 vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine).10
Use with caution in patients on anticoagulant therapy.
4 Data on file, Sanofi Pasteur SA.
10 Data on file, Sanofi Pasteur Inc.
14 ACIP. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. MMWR 40:No. RR-10, 1991.
15 Vaccine Adverse Event Reporting System United States. MMWR 39:730-733, 1990.
16 CDC. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200, 1988.
18 Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 10:311-314, 1991.
Read the ActHIB Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/21/2014
Additional ActHIB Information
Report Problems to the Food and Drug Administration
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