Haemophilus b Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein Conjugate) HibTITER is indicated for the immunization of children 2 months to 71 months of age against invasive diseases caused by H. influenza type b.

As with any vaccine, HibTITER may not protect 100% of individuals receiving the vaccine. HibTITER may be administered simultaneously but at different sites from other routine pediatric vaccines, eg, Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), Oral Poliovirus Vaccine (OPV), and Measles-Mumps-Rubella Vaccine (MMR).^32,33

HibTITER is for intramuscular use only.

Any parenteral drug product should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If these conditions exist, HibTITER should not be administered.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.

The vaccine should be injected intramuscularly, preferably into the midlateral muscles of the thigh or deltoid, with care to avoid major peripheral nerve trunks.

The vaccine is to be administered immediately after being drawn up into a syringe. Single dose 0.5 mL vial contains no preservative. Use one dose per vial; do not re-enter vial. Discard unused portions.

HibTITER is indicated for children 2 months to 71 months of age for the prevention of invasive Haemophilus b disease. For infants 2 to 6 months of age, the immunizing dose is three separate injections of 0.5 mL given at approximately 2-month intervals. Previously unvaccinated infants from 7 through 11 months of age should receive two separate injections approximately 2 months apart. Children from 12 through 14 months of age who have not been vaccinated previously receive one injection. All vaccinated children receive a single booster dose at 15 months of age or older, but not less than 2 months after the previous dose. Previously unvaccinated children 15 to 71 months of age receive a single injection of HibTITER.^32,33 Preterm infants should be vaccinated with HibTITER according to their chronological age, from birth.³²

Interruption of the recommended schedules with a delay between doses does not interfere with the final immunity achieved nor does it necessitate starting the series over again, regardless of the length of time elapsed between doses.^32,33

NO DATA ARE AVAILABLE TO SUPPORT THE INTERCHANGEABILITY OF HibTITER OR OTHER HAEMOPHILUS b CONJUGATE VACCINES WITH ONE ANOTHER FOR THE PRIMARY IMMUNIZATION SERIES. THEREFORE, IT IS RECOMMENDED THAT THE SAME CONJUGATE VACCINE BE USED THROUGHOUT EACH IMMUNIZATION SCHEDULE, CONSISTENT WITH THE DATA SUPPORTING APPROVAL AND

LICENSURE OF THE VACCINE.

Each dose of 0.5 mL is formulated to contain 10 mg of purified Haemophilus b saccharide and approximately 25 mg of CRM₁₉₇ protein.

Stability studies indicate that HibTITER can be shipped at ambient temperatures and stored at 2°C-8°C (36°F-46°F). DO NOT FREEZE.

Vial, 1 Dose (5 per package) Product No. 0005-0104-32

1. United States Patent Number 4,902,506 by Anderson PW, Eby filed May 5, 1986 issued February 20, 1990.

2. Seid RC Jr, Boykins RA, Liu DF, et al. Chemical evidence for covalent linkage of a semi-synthetic glycoconjugate vaccine for Haemophilus influenzae type b disease. Glycoconjugate J. 1989;6:489-498.

3. Wenger JD, Ward JL, Broome CV. Prevention of Haemophilus influenzae type b disease: vaccines and passive prophylaxis. In: Remington JS, Swartz MS, eds. Current Clinical Topics in Infectious Diseases. New York, NY: McGraw-Hill Inc; 1989;10: 306-339.

4. Recommendation of the Immunization Practices Advisory Committee (ACIP) polysaccharide vaccine for prevention of Haemophilus influenzae type b disease. MMWR. 1985;34:201-205.

5. Sell SH. Long term sequelae of bacterial meningitis in children. Pediatr Infect Dis J. 1983;2:90-93.

6. Broome CV. Epidemiology of Haemophilus influenzae type b infections in the United States.Pediatr Infect Dis J. 1987;6:779-782.

7. Alexander HE. The productive or curative element in type b Haemophilus influenzae rabbit serum. Yale J Biol Med. 1944;16:425-434.

8. Peltola H, Kayhty H, Sivonen A. 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. Pediatrics. 1977;60:730-737.

9. Robbins JB, Parke JC Jr, Schneerson R. Quantitative measurement of "natural" and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res. 1973;7:103-110.

10. Kayhty H, Peltola H, Karanko V, et al. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983;147:1100.

11. Kayhty H, Karanko V, Peltola H, et al. Serum antibodies after vaccination with Haemophilus influenzae type b capsular polysaccharide and responses to reimmunization: no evidence immunologic tolerance or memory. Pediatrics. 1984;74:857-865.

12. Weinberg GA, Granoff DM. Polysaccharide-protein conjugate vaccines for the prevention of Haemophilus influenzae type b disease. J Pediatr. 1988;113:621-631.

13. Makela O, Péterfy F, Outshoorn IG, et al. Immunogenic properties of a (1-6) dextran, its protein conjugates, and conjugates of its breakdown products in mice. Scand J Immunol 1984;19:541-550.

14. Anderson P, Pichichero ME, Insel RA. Immunogens consisting of oligosaccharides from Haemophilus influenzae type b coupled to diphtheria toxoid or the toxin protein CRM197. J Clin Invest. 1985;76:52-59.

15. Madore DV, Phipps DC, Eby R, et al. Immune response of young children vaccinated with Haemophilus influenzae type b conjugate vaccines. In: Cruse JM, Lewis RE, eds. Contributions to Microbiology and Immunology: Conjugate Vaccines. New York, NY: Karger Medical and Scientific Publishers; 1989;10:125-150.

16. Madore DV, Phipps DC, Eby R, et al. Safety and immunologic response to Haemophilus influenzae type b oligosaccharide-CRM197 conjugate vaccine in 1- to 6-month-old infants. Pediatrics. 1990;85:331-337.

17. Madore DV, Johnson CL, Phipps DC, et al. Safety and immunogenicity of Haemophilus influenzae type b oligosaccharide-CRM197 conjugate vaccine in infants aged 15-23 months. Pediatrics. 1990;86:527-534.

18. Rothstein EP, Madore DV, Long S. Antibody persistence four years after primary immunization of infants and toddlers with Haemophilus influenzae type b CRM197 conjugate vaccine. J Pediatr. 1991; 119:655-657.

19. Schlesinger Y, Granoff DM. Avidity and bactericidal activity of antibodies elicited by different Haemophilus influenzae type b conjugate vaccines. JAMA. 1992;267:1489-1494.

20. Unpublished data available from Lederle Laboratories.

21. Gigliotti F, Feldman S, Wang WC, et al. Immunization of young infants with sickle cell disease with a Haemophilus influenzae type b saccharide-diphtheria CRM197 protein conjugate vaccine. J Pediatr. 1989;114:1006-1010.

22. Black SB, Shinefield HR, The Kaiser Permanente Pediatric Vaccine Study Group. Immunization with oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine on a large health maintenance organization population: extended follow-up and impact on Haemophilus influenzae disease epidemiology. Pediatric Infect Dis J. 1992;11:610-613.

23. Black SB, Shinefield HR, Fireman B, et al. Safety, immunogenicity, and efficacy in infancy of oligosaccharide conjugate Haemophilus influenzae type b vaccine in a United States Population: possible implications for optimal use. J Infect Dis. 1992;165 (suppl 1):S139-S143.

24. Granoff DM, Anderson EL, Osterholm MT, et al. Differences in the immunogenicity of three Haemophilus influenzae type b conjugate vaccines in infants. J Pediatr. 1992;121:187-194.

25. Decker MD, Edwards KM, Bradley R, et al. Comparative trial in infants of four conjugate Haemophilus influenzae type b vaccines. J Pediatr. 1992;120:184-189.

26. Adams WG, Deaver KA, Cochi SL, et al. Decline of childhood Haemophilus influenzae type b (Hib) disease in the Hib vaccine era. JAMA. 1993;269:221-226.

27. Murphy TV, White KE, Pastor P, et al. Declining incidence of Haemophilus influenzae type b disease since introduction of vaccination. JAMA. 1993;269:246-248.

28. Broadhurst LE, Erickson RL, Kelley PW. Decreases in invasive Haemophilus influenzae diseases in US Army children, 1984 through 1991. JAMA. 1993;269:227-231.

29. Shapiro ED. Infections caused by Haemophilus influenzae type b: the beginning of the end? JAMA. 1993;269:264-266.

30. Black SB, Shinefield HR, Lampert D, et al. Safety and immunogenicity of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in infancy. Pediatr Infect Dis J. 1991;10:92-96.

31. Black SB, Shinefield HR, Fireman B, et al. Efficacy in infancy of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in a United States Population of 61,080 children. Pediatr Infect Dis J. 1991;10:97-104.

32. Recommendations of the AAP: Haemophilus influenzae type b conjugate vaccines: recommendations for immunization of infants and children 2 months of age and older: update. Pediatrics. 1991;88:169-172.

33. Recommendation of the ACIP: Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR. 1991;40:1-7.

34. Jones RG, Bass JW, Weisse ME, et al. Antigenuria after immunization with Haemophilus influenzae oligosaccharide CRM197 conjugate (HbOC) vaccine. Pediatr Infect Dis J. 1991;10:557-559.

35. American Academy of Pediatrics: Report of the Committee on Infectious Diseases. 22nd ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1991.

36. Recommendation of the ACIP - immunization of children infected with human T-lymphotrophic virus type III/lymphadenopathy-associated virus. MMWR 1986;35(38):595-606.

37. Immunization of Children infected with human immunodeficiency virus - supplementary ACIP statement. MMWR 1988;37(12):181-183.

38. General Recommendations on Immunization - recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1989;38(13):221.

39. Spinola SM, Sheaffer CI, Philbrick KB, et al. Antigenuria after Haemophilus influenzae type b polysaccharide immunization: a prospective study. J Pediatr. 1986;109:835-837.

40. CDC. Vaccine Adverse Event Reporting System - United States. MMWR. 1990;39:730-733.

41. Paradiso PR. Combined childhood immunizations. JAMA. 1992; 268:1685.

42. Milstein JB, Gross TP, Kuritsky JN. Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after one year of marketing. Pediatrics. 1987;80:270-274.

43. D'Cruz DF, Shapiro ED, Spiegelman KN, et al. Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome) after immunization with Haemophilus influenzae type b conjugate vaccine. J Pediatr. 1989;115:743-746.

Manufactured by: LEDERLE LABORATORIES, Division American Cyanamid Company Pearl River, NY 10965 USA, US GOVERNMENT LICENSE NO. 17

Marketed by: Wyeth-Ayerst Laboratories Philadelphia, PA 19101 USA, W10461C001 ET01

Rev 06/03

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