Adverse reactions associated with HibTITER have been evaluated in 401 infants who were vaccinated initially at 1 to 6 months of age and were given 1,118 doses independent of DTP vaccine. Observations were made during the day of vaccination and days 1 and 2 postvaccination. A temperature > 38.3°C was recorded at least once during the observation period following 2% of the vaccinations. Local erythema, warmth, or swelling ( ≥ 2 cm) was observed following 3.3% of vaccinations. The incidence of temperature > 38.3°C was greater during the first postvaccination day than during the day of vaccination or the second postvaccination day. The incidence of local erythema, warmth, or swelling was similar during the day of vaccination and the first postvaccination day; it was lower during the second postvaccination day. All side effects have been infrequent, mild, and transient with no serious sequelae (Table 1). No difference in the rates of these complaints was reported after dose 1, 2, or 3.

The following complaints were also observed after 1,118 vaccinations with HibTITER: irritability (133), sleepiness (91), prolonged crying [≥4 hours] (38), appetite loss (23), vomiting (9), diarrhea (2), and rash (1).

Additional safety data with HibTITER are available from the efficacy studies conducted in young infants.³⁰ There were 79,483 doses given to 30,844 infants at approximately 2, 4, and 6 months of age in California, usually at the same time as DTP (but at a separate injection site) and OPV; approximately 100,000 doses have been given to 53,000 infants at 4 and 6 months in Finland at the same time as a combined DTP and inactivated polio (IPV) vaccine (but at a separate injection site). The rate and type of reactions associated with the vaccinations were no different from those seen when DTP or DTP-IPV was administered alone. These included fever, local reactions, rash, and one hyporesponsive episode with a single seizure. The safety of HibTITER was also evaluated in the California study by direct phone questioning of the parents or guardians of 6,887 vaccine recipients. The incidence and type of side effects reported within 24 hours of vaccination were similar to those cited in Table 1. In addition, analysis of emergency room (ER) visits within 30 days and hospitalization within 60 days after receipt of 23,800 doses of HibTITER showed no increase in the rates of any type of ER visit or hospitalization.

Table 2 details the side effects associated with a single vaccination of HibTITER given (without DTP) to infants of 15 to 23 months of age.

Similar results have been observed in the analysis of 2,285 subjects of 18 to 60 months of age, vaccinated as part of a postmarketing safety study of HibTITER.²⁰ These data were collected by telephone survey 24 to 48 hours postvaccination. Additional observations included irritability, restless sleep, and Gl symptoms (diarrhea, vomiting, and loss of appetite) in the group that received HibTITER alone. A cause and effect relationship between these observations and the vaccinations has not been established.

*DTP and HibTITER given 2 weeks apart with DTP having been given first.

* The following complaints were reported after vaccination of these 354 children in the indicated number of children: diarrhea (9), vomiting (5), prolonged crying [>4 hours] (4), and rashes (2).

Rash, hives (urticaria), erythema multiforme, convulsions,⁴² vomiting/diarrhea,⁴² and

Guillain-Barré syndrome⁴³ have been observed following the administration of Haemophilus b polysaccharide and Haemophilus b conjugate vaccines. However, a cause and effect relationship among any of these events and the vaccination has not been established.

There have been spontaneous reports of apnea in temporal association with the administration of HibTITER. In most cases HibTITER was administered concomitantly with other vaccines including diphtheria tetanus pertussis vaccine (DTP), diphtheria tetanus acellular pertussis vaccine (DTaP), hepatitis B vaccine, inactivated polio vaccine (IPV), oral polio vaccine (OPV), pneumococcal 7-valent conjugate vaccine, measles-mumps-rubella (MMR), and/or meningococcal group C conjugate vaccine. In addition, in some of the reports existing medical conditions such as prematurity and/or history of apnea were present.

No impairment of the antibody response to the individual antigens was demonstrated when HibTITER was given at the same time but at separate sites as DTP plus OPV to children 2 to 20 months of age or MMR to children 15 ��1 month of age.^20,41 As with other intramuscular injections, HibTITER should be given with caution to children on anticoagulant therapy.

HibTITER has not been evaluated for its carcinogenic, mutagenic potential, or impairment of fertility.

REPRODUCTIVE STUDIES PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with HibTITER. It is also not known whether HibTITER can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. HibTITER is NOT recommended for use in a pregnant woman.

This vaccine is NOT recommended for use in adult populations.

The safety and effectiveness of HibTITER in children below the age of 6 weeks have not been established.

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