Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization. 33,34 (See PRECAUTIONS, General .)
As with other intramuscular injections, Prevnar® should be given with caution to children on anticoagulant therapy.
Simultaneous Administration with Other Vaccines
During clinical studies, Prevnar® was administered simultaneously with DTaP and HbOC, IPV, Hep B vaccines, MMR, and Varicella vaccine. Thus, the safety experience with Prevnar® reflects the use of this product as part of the routine immunization schedule. 20,21, 25,27, 28,30
The immune response to routine vaccines when administered with Prevnar® (at separate sites) was assessed in 3 clinical studies in which there was a control group for comparison. Higher antibody levels (GMC) to Hib were observed after 3 doses of HbOC given with Prevnar in the infant series, compared to HbOC without Prevnar. After the 4th dose, Hib GMCs were lower when HbOC was given with Prevnar compared to control; however, over 97% of children receiving HbOC with Prevnar achieved a serum antibody concentration of ≥1 Î¼g/mL. Although some inconsistent differences in response to pertussis antigens were observed, the clinical relevance is unknown. The response to 2 doses of IPV given concomitantly with Prevnar®, assessed 3 months after the second dose, was equivalent to controls for poliovirus Types 2 and 3, but lower for Type 1. In another study, over 98% of subjects achieved neutralizing antibody titers ≥1:8 for all polio types, following a third dose of IPV given concomitantly with Prevnar at 12 months of age. 35 Seroresponse rates to measles, mumps and rubella were similar after MMR was given concomitantly with Prevnar at 12 months of age compared to seroresponse rates after MMR was given without Prevnar at 12 months of age. 36 A clinical study demonstrated no interference with the immune response to varicella vaccine when administered concurrently with a 4th dose of Prevnar®. 37
There have been reports of overdose with Prevnar®, including cases of administration of a higher than recommended dose and cases of subsequent doses administered closer than recommended to the previous dose. Most individuals were asymptomatic. In general, adverse events reported with overdose have also been reported with recommended single doses of Prevnar®.
Hypersensitivity to any component of the vaccine, including diphtheria toxoid, is a contraindication to use of this vaccine.
- Schuchat A, Robinson K, Wenger JD, et al. Bacterial meningitis in the United States in 1995. N Engl J Med. 1997; 337:970-6.
- Zangwill KM, Vadheim CM, Vannier AM, et al. Epidemiology of invasive pneumococcal disease in Southern California: implications for the design and conduct of a pneumococcal conjugate vaccine efficacy trial. J Infect Dis. 1996; 174:752-9.
- Breiman R, Spika J, Navarro V, et al. Pneumococcal bacteremia in Charleston County, South Carolina. Arch Intern Med. 1990; 150:1401-5.
- Levine O, Farley M, Harrison LH, et al. Risk factors for invasive pneumococcal disease in children: a population-based case-control study in North America. Pediatrics. 1999; 103:1-5.
- Kaplan SL, Mason EO, Barson WJ, et al. Three-year multicenter surveillance of systemic pneumococcal infections in children. Pediatrics. 1998; 102:538-44.
- Arditi M, Mason E, Bradley J, et al. Three-year multicenter surveillance of pneumococcal meningitis in children: clinical characteristics and outcome related to penicillin susceptibility and dexamethasone use. Pediatrics. 1998; 102:1087-97.
- Shappert SM. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 1997. National Center for Health Statistics. Vital Health Sat. 1999; 13(143):1-41.
- Hall MJ, Lawrence L. Ambulatory surgery in the United States, 1996. Adv Data Vital Health Stat. 1998; 300:1-16.
- Teele DW, Klein JO, Rosner B, et al. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis. 1989; 160:83-94.
- Shappert, SM. Office visits for otitis media: United States, 1975-1990. Adv Data Vital Health Stat. 1992; 214:1-20.
- Bluestone CD, Stephenson BS, Martin LM. Ten-year review of otitis media pathogens. Pediatr Infect Dis J. 1992; 11:S7-S11.
- Giebink GS. The microbiology of otitis media. Pediatr Infect Dis J. 1989; 8:S18-S20.
- Rodriguez WJ, Schwartz RH. Streptococcus pneumoniae causes otitis media with higher fever and more redness of tympanic membrane than Haemophilus influenzae or Moraxella catarrhalis . Pediatr Infect Dis J. 1999; 18:942-4.
- Barnett ED, Klein JO. The problem of resistant bacteria for the management of acute otitis media. Ped Clin North Am. 1995; 42:509-17.
- Butler JC, Breiman RF, Lipman HB, et al. Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. J Infect Dis. 1995; 171:885-9.
- Paisley JW, Lauer BA, McIntosh K, et al. Pathogens associated with acute lower respiratory tract infection in young children. Pediatr Infect Dis J. 1984; 3:14-9.
- American Academy of Pediatrics Committee on Infectious Diseases. Therapy for children with invasive pneumococcal infections. Pediatrics. 1997; 99:289-300.
- Hausdorff WP, Bryant J, Paradiso PR, Siber GR. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis. 2000; 30:100-21.
- Bulter JC, Hoffman J, Cetron MS, et al. The continued emergence of drug-resistant Streptococcus pneumoniae in the United States. An Update from the Centers for Disease Control and Prevention's Pneumococcal Sentinel Surveillance System. J Infect Dis. 1996; 174:986-93.
- Lederle Laboratories, Data on File: D118-P8.
- Black S, Shinefield H, Ray P, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000; 19:187-195.
- Lederle Laboratories, Data on File: D118-P809.
- Eskola J, Kilpi T, Palma A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001; 344:403-409.
- Fireman B, Black S, Shinefield H, et al. The impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J. 2003;22:10-16.
- Lederle Laboratories, Data on File: D118-P16.
- Lederle Laboratories, Data on File: D118-P8 Addendum DTaP Immunogenicity.
- Shinefield HR, Black S, Ray P. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 1999; 18:757-63.
- Lederle Laboratories, Data on File: D118-P12.
- Rennels MD, Edwards KM, Keyserling HL, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics. 1998; 101(4):604-11.
- Lederle Laboratories, Data on File: D118-P3.
- Lederle Laboratories, Data on File: Integrated Summary on Catch-Up.
- Report of the Committee on Infectious Diseases 24th Edition. Elk Grove Village, IL: American Academy of Pediatrics. 1997; 31-3.
- Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions. MMWR. 1996; 45 (RR-12):1-35.
- Centers for Disease Control and Prevention. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR. 2002; 51(RR-2):1-36.
- Wyeth, Data on file: Final clinical study report D140-P1.
- Wyeth, Data on file: Final clinical study report MMR100495.
- Wyeth, Data on file: Final clinical study report, Addendum MMR100495: Varicella immunogenicity.
- Wyeth, Data on file: Final clinical study report 0887X-100722.
- Vernacchio L, Neufeld EJ, MacDonald K, et al. Combined schedule of 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal vaccine in children and young adults with sickle cell disease. J Pediatr . 1998;103:275-278.
- Fawcett HA, Smith NP. Injection-site granuloma due to aluminum. Archives Dermatology. 1984; 120:1318-22.
- Wyeth, Data on file: Final clinical study report 100494.
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- Vaccines Adverse Event Reporting System United States. MMWR. 1990; 39:730-3.
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