Vaccine Information: PedvaxHIB (Page 3 of 4)

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

DOSAGE AND ADMINISTRATION

Liquid PedvaxHIB

FOR INTRAMUSCULAR ADMINISTRATION

DO NOT INJECT INTRAVENOUSLY

If there is an interruption or delay between doses in the primary series, there is no need to repeat the series, but dosing should be continued at the next clinic visit. (See CONTRAINDICATIONS and PRECAUTIONS.)

2 to 14 Months of Age

Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine ideally beginning at 2 months of age followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary two-dose regimen is completed before 12 months of age, a booster dose is required (see below and TABLE 6). Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.{46}

15 Months of Age and Older

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

Booster Dose

In infants completing the primary two-dose regimen before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months of age, but not earlier than 2 months after the second dose.

Vaccination regimens for Liquid PedvaxHIB by age group are outlined in TABLE 6.

TABLE 6: Vaccination Regimens for Liquid PedvaxHIB By Age Groups
Age (Months)at First Dose Primary Age (Months)at Booster Dose
2–10 2 doses, 2 mo. apart 12–15
11–14 2 doses, 2 mo. apart
15–71 1 dose

Interchangeability

PedvaxHIB may be interchanged with other licensed Haemophilus b Conjugate Vaccines for the primary and booster doses.{52} (See CLINICAL PHARMACOLOGY.)

Use with Other Vaccines

Results from clinical studies indicate that Liquid PedvaxHIB can be administered concomitantly with DTP, OPV, eIPV (enhanced inactivated poliovirus vaccine), VARIVAX [Varicella Virus Vaccine Live (Oka/Merck)], M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) or RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)]. No impairment of immune response to these individually tested vaccine antigens was demonstrated.

The type, frequency and severity of adverse experiences observed in these studies with PedvaxHIB were similar to those seen with the other vaccines when given alone. (See CLINICAL PHARMACOLOGY.)

In addition, a PRP-OMPC-containing product, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with a booster dose of DTaP [diphtheria, tetanus, acellular pertussis] at approximately 15 months of age, using separate sites and syringes for injectable vaccines. No impairment of immune response to these individually tested vaccine antigens was demonstrated. COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. PRP antibody responses are satisfactory for COMVAX, but immune responses are currently unavailable for DTaP (see Manufacturer’s Product Circular for COMVAX). No serious vaccine-related adverse events were reported.{33}

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.

Liquid PedvaxHIB is a slightly opaque white suspension. (See DESCRIPTION.)

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Inject 0.5 mL intramuscularly, preferably into the anterolateral thigh or the outer aspect of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve. Discard vial after use.

HOW SUPPLIED

Liquid PedvaxHIB is supplied as follows:

No. 4897 — A box of 10 single-dose vials of liquid vaccine, NDC 0006-4897-00.

Storage

Store vaccine at 2-8°C (36-46°F).

DO NOT FREEZE.

REFERENCES

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  2. Schlech, W. F., III, et al: Bacterial meningitis in the United States, 1978 through 1981. The National Bacterial Meningitis Surveillance Study. JAMA 253: 1749-1754, 1985.
  3. Peltola, H., et al: Prevention of Haemophilus influenzae type b bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med 310: 1561-1566, 1984.
  4. Cadoz, M., et al: Etude epidemiologique des cas de meningitis purulentes hospitalises a Dakar pendant la decemie 1970-1979. Bull WHO 59: 575-584, 1981.
  5. Sell, S. H., et al: Long-term Sequelae of Haemophilus influenzae meningitis. Pediatr 49: 206-217, 1972.
  6. Taylor, H. G., et al: Intellectual, neuropsychological, and achievement outcomes in children six to eight years after recovery from Haemophilus influenzae meningitis. Pediatr 74: 198-205, 1984.
  7. Hay, J. W., et al: Cost-benefit analysis of two strategies for prevention of Haemophilus influenzae type b infection. Pediatr 80 (3): 319-329, 1987.
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  10. Fraser, D.W., et al: Risk factors in bacterial meningitis: Charleston County, South Carolina. J Infect Dis 127: 271-277, 1973.
  11. Tarr, P. I., et al: Demographic factors in the epidemiology of Haemophilus influenzae meningitis in young children. J Pediatr 92: 884-888, 1978.
  12. Granoff, D. M., et al: Response to immunization with Haemophilus influenzae type b polysaccharide-pertussis vaccine and risk of Haemophilus meningitis in children with Km(1) immunoglobulin allotype. J Clin Invest 74: 1708-1714, 1984.
  13. Ambrosino, D. M., et al: Correlation between G2m(n) immunoglobulin allotype and human antibody response and susceptibility to polysaccharide encapsulated bacteria. J Clin Invest 75: 1935-1942, 1985.
  14. Coulehan, J. L., et al: Epidemiology of Haemophilus influenzae type b disease among Navajo Indians. Pub Health Rep 99: 404-409, 1984.
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  24. Robbins, J. B., et al: Quantitative measurement of ‘natural’ and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res 7: 103-110, 1973.
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  27. Ward, J. I., et al: Haemophilus influenzae type b vaccines: Lessons For the Future. Pediatr 81: 886-893, 1988.
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  29. Marburg, S., et al: Bimolecular chemistry of macromolecules: Synthesis of bacterial polysaccharide conjugates with Neisseria meningitidis membrane protein. J Am Chem Soc 108: 5282-5287, 1986.
  30. Letson, G. W., et al: Comparison of active and combined passive/active immunization of Navajo children against Haemophilus influenzae type b. Pediatr Infect Dis J 7 (111): 747-752, 1988.
  31. Einhorn, M. S., et al: Immunogenicity in infants of Haemophilus influenzae type b polysaccharide in a conjugate vaccine with Neisseria meningitidis outer-membrane protein. Lancet 2: 299-302, 1986.
  32. Ahonkhai, V.I., et al: Haemophilus influenzae type b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB TM): Clinical Evaluation. Pediatr 85 (4): 676-681, 1990.
  33. Data on file at Merck Research Laboratories.
  34. Granoff, D. M., et al: Immunogenicity of Haemophilus influenzae type b polysaccharide—outer membrane protein conjugate vaccine in patients who acquired Haemophilus disease despite previous vaccination with type b polysaccharide vaccine. J. Pediatr. 114 (6): 925-933, June 1989.
  35. Lenoir, A. A., et al: Response to Haemophilus influenzae type b (H. influenzae type b) polysaccharide N. meningitidis outer membrane protein (PS-OMP) conjugate vaccine in relation to Km(1) and G2m(23) allotypes. Twenty-sixth Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #216) 133, 1986.
  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.
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  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.
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