SIDE EFFECTS

When ProHIBiT (haemophilus b conjugate vaccine) ® alone was given to over 1,000 adults and children, no serious adverse reactions were observed.^15,20,25,34 Thrombocytopenia was seen in one adult but a causative relationship was not established.

When ProHIBiT (haemophilus b conjugate vaccine) ® was given with DTP and Inactivated Poliovirus Vaccine (IPV) to 55,000 Finnish children, the rate and extent of serious adverse reactions were not different from those seen when DTP or IPV were administered alone.^25,35 Allergic reactions such as urticaria were infrequently observed.^15,35

Adverse reactions following vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® (without DTP) in subjects 15 to 24 months of age are summarized in Table 6.³⁴

TABLE 6³⁴: Percentage of Subjects 15 to 24 Months of Age Developing Local or Systemic Reactions to One Dose of Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate)

Other adverse reactions temporally associated with administration of ProHIBiT (haemophilus b conjugate vaccine) ® including diarrhea, vomiting, and crying were reported at a frequency of ≤ 1.2%. Fever of 39°C or more occurred in < 1%, while irritability, sleepiness, or anorexia were reported in 16.1%.³⁴

Adverse reactions in clinical evaluations among 689 children, 7 to 14 months of age, 24 hours after receiving a single dose of ProHIBiT (haemophilus b conjugate vaccine) ® , were observed and compared to 139 children who received a saline placebo. There were no significant differences in the reaction rates for fever, erythema, induration, and tenderness between the two groups.¹⁵

A post-marketing surveillance study was conducted between April 1988 and July 1989 in the United States in 50,007 children 16 to 60 months of age. At Southern California Kaiser Permanente, 29,309 of these children were followed closely to determine the number of systemic and local reactions occurring within 6, 24, and 48 hours post-vaccination with ProHIBiT (haemophilus b conjugate vaccine) ® alone. These reactions are summarized in Table 7.¹⁵

TABLE 7¹⁵: Post-Marketing Surveillance Study in Subjects 16-60 Months of Age Experiencing Adverse Reactions (n=29,309)

In 50 children who had received licensed Haemophilis b Conjugate Vaccine in infancy and a booster dose of ProHIBiT (haemophilus b conjugate vaccine) ® at 12 months of age, the adverse experience profile was similar as summarized in Table 8.¹⁵

TABLE 8¹⁵: Adverse Experiences with ProHIBiT (haemophilus b conjugate vaccine) ® given as a Booster at 12 to 15 Months of Age Primary Series either with Haemophilus b Conjugate Vaccine (Diphtheria CRM₁₉₇Protein Conjugate) or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (n=50)

Other adverse reactions reported with administration of ProHIBiT (haemophilus b conjugate vaccine) ®  included urticaria, seizure, and renal failure.^15,34 Guillain-Barré syndrome (GBS) rarely has been reported.³⁶ However, a cause and effect relationship for these adverse events has not been established.

Reporting of Adverse Events

Reporting by parents or guardians 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.^32,33,37

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

Read the entire FDA prescribing information for Prohibit (Haemophilus b Conjugate Vaccine) »