Liquid PedvaxHIB

In a multicenter clinical study (n=903) comparing the effects of Liquid PedvaxHIB with those of lyophilized PedvaxHIB, 1,699 doses of Liquid PedvaxHIB were administered to 678 healthy infants 2 to 6 months of age from the general U.S. population. DTP and OPV were administered concomitantly to most subjects. Both formulations of PedvaxHIB were generally well tolerated and no serious vaccine-related adverse reactions were reported.

During a three-day period following primary vaccination with Liquid PedvaxHIB in these infants, the most frequently reported ( > 1%) adverse reactions, without regard to causality, excluding those shown in TABLE 5, in decreasing order of frequency, were: irritability, sleepiness, injection site pain/soreness, injection site erythema ( ≤ 2.5 cm diameter, see also TABLE 5), injection site swelling/induration ( ≤ 2.5 cm diameter, see also TABLE 5), unusual high-pitched crying, prolonged crying ( > 4 hr), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

Selected objective observations reported by parents over a 48-hour period in these infants following primary vaccination with Liquid PedvaxHIB are summarized in TABLE 5.

TABLE 5
Fever or Local Reactions in Subjects First Vaccinated at 2 to 6 Months of Age with Liquid PedvaxHIB*

Adverse reactions during a three-day period following administration of the booster dose were generally similar in type and frequency to those seen following primary vaccination.

Lyophilized PedvaxHIB

In The Protective Efficacy Study (see CLINICAL PHARMACOLOGY), 4,459 healthy Navajo infants 6 to 12 weeks of age received lyophilized PedvaxHIB or placebo. Most of these infants received DTP/OPV concomitantly. No differences were seen in the type and frequency of serious health problems expected in this Navajo population or in serious adverse experiences reported among those who received lyophilized PedvaxHIB and those who received placebo, and none was reported to be related to lyophilized PedvaxHIB. Only one serious reaction (tracheitis) was reported as possibly related to lyophilized PedvaxHIB and only one (diarrhea) as possibly related to placebo. Seizures occurred infrequently in both groups (9 occurred in vaccine recipients, 8 of whom also received DTP; 8 occurred in placebo recipients, 7 of whom also received DTP) and were not reported to be related to lyophilized PedvaxHIB.

In early clinical studies involving the administration of 8,086 doses of lyophilized PedvaxHIB alone to 5,027 healthy infants and children 2 months to 71 months of age, lyophilized PedvaxHIB was generally well tolerated. No serious adverse reactions were reported. In a subset of these infants, urticaria was reported in two children, and thrombocytopenia was seen in one child. A cause and effect relationship between these side effects and the vaccination has not been established.

Potential Adverse Reactions

The use of Haemophilus b Polysaccharide Vaccines and another Haemophilus b Conjugate Vaccine has been associated with the following additional adverse effects: early onset Hib disease and Guillain-Barré syndrome. A cause and effect relationship between these side effects and the vaccination was not established.^{36,37,39,40,41,49}

Post-Marketing Adverse Reactions

The following additional adverse reactions have been reported with the use of the lyophilized and liquid formulations of PedvaxHIB:

Hemic and Lymphatic System

Lymphadenopathy

Hypersensitivity

Rarely, angioedema

Nervous System

Febrile seizures

Skin

Sterile injection site abscess

No information provided.

REFERENCES

36. Mortimer, E. A.: Efficacy of Haemophilus b polysaccharide vaccine: An enigma. JAMA 260: 1454, 1988.

37. Meekison, W., et al: Post-marketing surveillance of adverse effects following ProHIBiT vaccine. British Columbia Canada Diseases Weekly Report 15-28: 143-145, 1989.

38. Goepp, J. G., et al: Persistent urinary antigen excretion in infants vaccinated with Haemophilus influenzae type b capsular polysaccharide conjugated with outer membrane protein from Neisseria meningitidis. Pediatr Infect Dis J 11(1): 2-5, 1992.

39. Milstein, J. B., et al: Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: An analysis after one year of marketing. Pediatr 80: 270, 1987.

40. Black, S., et al: b-CAPSA 1 Haemophilus influenzae type b capsular polysaccharide vaccine safety. Pediatr 79: 321-325, 1987.

41. D'Cruz, O. F., et al: Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome) after immunization with Haemophilus influenzae type b Conjugate Vaccine. J Pediatr 115: 743-746, 1989.

49. Keyserling, H.L., et al: Program and Abstracts of the 30th ICAAC, (Abstract #63), 1990.

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