- « Previous
- Clinical Pharmacology
- Next »
Pedvax HIB
Clinical Pharmacology
Pedvax HIB
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)].33 No impairment of immune response to individual tested vaccine antigens was demonstrated.
The type, frequency and severity of adverse experiences observed in these studies with PedvaxHIB were similar to those seen when the other vaccines were given alone.
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
REFERENCES
1. Cochi, S. L., et al: Immunization of U.S. children with Haemophilus influenzae type b polysaccharide vaccine: A cost- effectiveness model of strategy assessment. JAMA 253: 521-529, 1985.
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.
8. Redmond, S. R., et al: Haemophilus influenzae type b disease: an epidemiologic study with special reference to daycare centers. JAMA 252: 2581-2584, 1984.
9. Istre, G. R., et al: Risk factors for primary invasive Haemophilus influenzae disease: increased risk from daycare attendance and school age household members. J Pediatr 106: 190-195, 1985.
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.
15. Losonsky, G. A., et al: Haemophilus influenzae disease in the White Mountain Apaches: molecular epidemiology of a high risk population. Pediatr Infect Dis J 3: 539-547, 1985.
16. Ward, J. I., et al: Haemophilus influenzae disease in Alaskan Eskimos: characteristics of a population with an unusual incidence of disease. Lancet 1: 1281-1285, 1981.
17. Ward, J. I., et al: Haemophilus influenzae meningitis: a national study of secondary spread in household contacts. N Engl J Med 301: 122-126, 1979.
18. Ward, J., et al: Haemophilus influenzae bacteremia in children with sickle cell disease. J Pediatr 88: 261-263, 1976.
19. Bartlett, A. V., et al: Unusual presentations of Haemophilus influenzae infections in immunocompromised patients. J Pediatr 102: 55-58, 1983.
20. Recommendations of the Immunization Practices Advisory Committee. Polysaccharide vaccine for prevention of Haemophilus influenzae type b disease. MMWR 34(15): 201-205, 1985.
21. Santosham, M., et al: Prevention of Haemophilus influenzae type b infections in high-risk infants treated with bacterial polysaccharide immune globulin. N Engl J Med 317: 923-929, 1987.
22. Siber, G. R., et al: Preparation of human hyperimmune globulin to Haemophilus influenzae b, Streptococcus pneumoniae, and Neisseria meningitidis. Infect Immun 45: 248-254, 1984.
23. Smith, D. H., et al: Responses of children immunized with the capsular polysaccharide of Haemophilus influenzae type b. Pediatr 52: 637-645, 1973.
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.
25. Kaythy, H., et al: The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 147: 1100, 1983.
26. Peltola, H., et al: Haemophilus influenzae type b capsular polysaccharide vaccine in children: a double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland. Pediatr 60: 730-737, 1977.
27. Ward, J. I., et al: Haemophilus influenzae type b vaccines: Lessons For the Future. Pediatr 81: 886-893, 1988.
28. Daum, R. S., et al: Haemophilus influenzae type b vaccines: Lessons From the Past. Pediatr 81: 893-897, 1988.
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.
42. Recommendations of the Immunization Practices Advisory Committee. Recommendations for use of Haemophilus b Conjugate Vaccines and a combined diphtheria, tetanus, pertussis, and Haemophilus b vaccine. MMWR 42(RR-13): 1-15, 1993.
43. Daum, R. S., et al: Interchangeability of Haemophilus influenzae type b vaccines for the primary series (mix and match): a preliminary analysis [Abstract 976]. Pediatr Res 33: 166A, 1993.
44. Greenberg, D. P., et al: Enhanced antibody responses in infants given different sequences of heterogenous Haemophilus influenzae type b Conjugate Vaccines. J Pediatr 126: 206-211, 1995.
45. Anderson, E. L., et al: Interchangeability of Conjugated Haemophilus influenzae type b Vaccines in Infants. JAMA 273: 849-853, 1995.
52. American Academy of Pediatrics. Recommended Childhood Immunization Schedule - United States, January- December 1998. Pediatr 101(1): 154-157, 1998.
Generic Name: Haemophilus b Conjugate Vaccine
- « Previous
- Clinical Pharmacology
- Next »
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Living Better
Find the secrets to longer life.
Medicine Cabinet Makeover
When you’re sick, you don't want to go shopping for medicine. Find out how you can be prepared.See more WebMD Videos »
