ProHIBiT ® is indicated for immunization against invasive diseases caused by Haemophilus influenzae type b.^25,26 ProHIBiT ® may be administered as a booster vaccination at 12 to 15 months of age in children who received primary immunization with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) or Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate) as illustrated in Tables 2, 3, 4 and 5. This vaccine also may be administered as primary immunization at 15 months of age in children who have not received primary immunization with any licensed Haemophilus b Conjugate Vaccine.

* Comparison of the booster immunogenicity data at 12 and 15 months showed equivalent antibody titers (p = 0.3115), analysis of variance.

** Comparison of the percentages of 12- and 15- month- old infants who responded with a PRP antibody response >/=1.00 µg/ mL showed no significant difference (p = 0.267), Chi- square test.

* Comparison of the booster immunogenicity data at 12 and 15 months showed equivalent antibody titers (p = 0.1104), analysis of variance.

** Comparison of the percentages of 12 and 15- month- old infants who responded with a PRP antibody response >/= 1.00 µg/ mL showed no significant difference (p = 0.290), Chi- square test.

Children With Symptomatic Human Immunodeficiency Virus (Hiv) Infection Immunization with Haemophilus b Conjugate Vaccine is recommended by the American Academy of Pediatrics (Red Book) and Immunization Practices Advisory Committee (ACIP) for children who are immunosuppressed in association with AIDS or any other immunodeficiency disease.^26,27

ProHIBiT ® will not protect against Haemophilus influenzae other than type b or other microorganisms that cause meningitis or septic disease.

No impairment of the immune response to the individual antigens was demonstrated when ProHIBiT ® and Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) were given at the same time in separate syringes at different sites.^15,28

Limited data are available on concomitant administration of ProHIBiT ® with MMR, and OPV (IPV). Fourteen- month- old Finnish children boosted with PRP- D received MMR concomitantly. Pre and 4 weeks post sera from a small subset (11 patients), showed no significant difference in antibody response to Measles, Mumps, or Rubella antigens when compared to a group that received MMR alone. A group of 25 Finnish infants received concomitant DTP, PRP- D, and IPV was compared to a group of 25 receiving DTP and IPV only. No significant difference in response to Type 1, Type 2, or Type 3 polio antigens was noted. Response to oral Polio Vaccine was evaluated in 31 infants immunized with PRP- D who also received OPV concomitantly. No difference in response to Type 1, Type 2, or Type 3 antigens was observed when compared to 22 infants receiving placebo and OPV.^15,29

ProHIBiT ® IS NOT RECOMMENDED FOR USE IN CHILDREN YOUNGER THAN 12 MONTHS OF A.E.

Parenteral drug products should be inspected visually for extraneous particulate matter and or discoloration prior to administration whenever solution and container permit. If these conditions exist, the vaccine should not be administered.

The immunizing dose is a single injection of 0.5 mL given intramuscularly in the outer aspect area of the vastus lateralis (mid- thigh) or deltoid.

Each 0.5 mL dose contains 25 µg of purified capsular polysaccharide and 18 µg of conjugated diphtheria toxoid protein. Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

DO NOT INJECT INTRAVENOUSLY.

A booster dose of ProHIBiT ® should be administered to children 12 to 15 months of age previously immunized with any licensed Hib conjugate vaccine. A single dose of ProHIBiT ® should be administered to children 15 months of age and older, not previously immunized with a Hib conjugate vaccine.

Vial, 1 Dose (5 per package) † Product No. 49281- 541- 01

Vial, 5 Dose † Product No. 49281- 541- 05

Vial, 10 Dose † Product No. 49281- 541- 10

STORAGE

Store between 2° † 8° C (35° † 46° F). DO NOT FREEZE.

 REFERENCES

1. Recommendations of the Immunization Practices Advisory Committee (ACIP). Polysaccharide vaccine for prevention of Haemophilus influenzaetype b disease. MMWR 34: 201- 205, 1985
2. Cochi SL, et al. Immunization of US children with Haemophilus influenzaetype b polysaccharide vaccine: A cost- effectiveness model of strategy assessment. JAMA 253: 521- 529, 1985
3. Murphy TV, et al. Prospective surveillance of Haemophilus influenzae type b disease in Dallas County, Texas, and in Minnesota. Pediatr 79: 173- 179, 1987
4. Broome CV. Epidemiology of Haemophilus influenzaetype b infections in the United States. Pediatr Infect Dis J 6: 779- 782, 1987
5. Istre GR, et al. Risk factors for primary invasive Haemophilus influenzae disease: Increased risk from day care attendance and school- aged household members. J Pediatr 106: 190- 195, 1985
6. Redmond SR, et al. Haemophilus influenzae type b disease. An epidemiologic study with special reference to day- care centers. JAMA 252: 2581- 2584, 1984
7. Murphy TV, et al. County- wide surveillance of invasive Haemophilus infections: Risk of associated cases in Child Care Programs (CCPs). Twenty- third Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #788) 229, 1983
8. Fleming D, et al. Haemophilus influenzaeb (Hib) disease † secondary spread in day care. Twenty- fourth Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #967) 261, 1984
9. CDC. Prevention of secondary cases of Haemophilus influenzaetype b disease. MMWR 31: 672- 680, 1982
10. Michaels RH, et al. Pharyngeal colonization with Haemophilus influenzae type b: A longitudinal study of families with a child with meningitis or epiglottitis due to H. influenzaetype b. J Infec Dis 136: 222- 227, 1977
11. 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
12. Smith DH, et al. Responses of children immunized with the capsular polysaccharide of Haemophilus influenzae, type b. Pediatr 52: 637- 644, 1973
13. Robbins JB, et al. Quantitative measurement of "natural" and immunization- induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res 7: 103- 110, 1973
14. Robbins JB, et al. A review of the efficacy trials with Haemophilus influenzaetype b polysaccharide vaccines. In: Sell, S. H., Wright, P. E. eds. Haemophilus influenzae. New York: Elsevier Biomedical. 255- 263, 1982
15. Unpublished data available from Connaught Laboratories, Inc.
16. Granoff DM, et al. Immunogenicity of Haemophilus influenzaetype b polysaccharide- diphtheria toxoid conjugate vaccine in adults. J Pediatr 105: 22- 27, 1984
17. Cates KL. Serum opsonic activity for Haemophilus influenzae type b in infants immunized with polysaccharide- protein conjugate vaccines. J Infec Dis 152: 1076- 1077, 1985
18. Benacerraf B, et al. Textbook of Immunology. Cellular interactions. Williams and Wilkins, p 22, 1979
19. Schneerson R, et al. Preparation, characterization, and immunogenicity of Haemophilus influenzae type b polysaccharide- protein conjugates. J Exp Med 152: 361- 376, 1980
20. Lepow ML, et al. Safety and immunogenicity of Haemophilus influenzaetype b- polysaccharide diphtheria toxoid conjugate vaccine in infants 9 to 15 months of age. J Pediatr 106: 185- 189, 1985
21. Greenberg DP, et al. Variability in quantitation of Haemophilus influenzae type b anticapsular antibody (anti- PRP) by radioimmunoassay (RIA). Twenty- sixth Interscience Conference on Antimicrobial Agents and Chemotherapy (Abstract #209) 133, 1986
22. Frank AL, et al. Haemophilus influenzaeType b immunization of children with sickle cell diseases. Pediatr 82: 571- 575, 1988
23. Plotkin SA, et al. Vaccines. Haemophilus influenzaevaccines. W. B. Saunders Co. p 318, 1988
24. Gigliotti F, et al. Response of children with acute lymphoblastic leukemia (ALL) to H. influenzaetype b (Hib) conjugate vaccine. The Society for Pediatric Research (Serial #11595), 1988
25. ACIP † Update. Prevention of Haemophilus influenzaetype b disease. MMWR 37: 13- 16, 1988
26. Report of the Committee on Infectious Diseases, ed 22. Elk Grove Village, IL, American Academy of Pediatrics, 1991
27. ACIP. Immunization of children infected with human immunodeficiency virus † Supplementary ACIP statement. MMWR 37: 181- 183, 1988
28. Hendley JO, et al. Immunogenicity of Haemophilus influenzae type b capsular polysaccharide vaccines in 18- month- old infants. Pediatr 80: 351- 354, 1987
29. Eskola J, et al. Simultaneous administration of Haemophilus influenzaetype b capsular polysaccharide- diphtheria toxoid conjugate vaccine with routine diphtheria- tetanus- pertussis and inactivated poliovirus vaccinations of childhood. Pediatr Infect Dis J 7: 480- 484, 1988
30. FDA Workshop on Haemophilus b Polysaccharide Vaccine † A Preliminary Report, MMWR 36: 529- 531, 1987
31. Scheifele D, et al. Antigenuria after receipt of Haemophilus b Diphtheria Toxoid Conjugate Vaccine. Pediatr Infect Dis J 8: 887- 888, 1989
32. National Childhood Vaccine Injury Act of 1986 (Amended 1987)
33. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197- 200, 1988
34. Berkowitz CD, et al. Safety and immunogenicity of Haemophilus influenzae type b polysaccharide and polysaccharide diphtheria toxoid conjugate vaccines in children 15 to 24 months of age. J Pediatr 110: 509- 514, 1987
35. Eskola J, et al. Efficacy of Haemophilus influenzae type b polysaccharide diphtheria toxoid conjugate vaccine in infancy. N Engl J Med 317: 717- 722, 1987
36. D†Cruz OF, et al. Acute inflammatory demyelinating polyradiculoneuropathy (Guillain- Barré Syndrome) after immunization with Haemophilus influenzaetype b conjugate vaccine. J Pediatr 115: 743- 746, 1989
37. Vaccine Adverse Event Reporting System † United States. MMWR 39: 730- 733, 1990

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