Clinical Evaluation of Pediarix: A New Pediatric Combination Vaccine

1. Centers for Disease Control and Prevention . Recommended childhood immunization schedule: United States, 2002. MMWR. 2002;51:31-33.

2. IPOL prescribing information. Swiftwater, PA: Aventis Pasteur Inc; 1999.

3. Yeh SH , Ward JI , Partridge S , et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr Infect Dis J. 2001;20:973-980.

4. Zepp F , Schuind A , Meyer C , et al. Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given along with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants. Pediatrics. 2002;109:e58-e58.

5. Engerix-B prescribing information. Philadelphia, PA: Smith Kline Beecham Pharmaceuticals; 2001.

6. Infanrix prescribing information. Philadelphia, PA: Smith Kline Beecham Pharmaceuticals; 2001.

7. Atkinson W , Wolfe C , eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 7th ed. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2002.

8. Plotkin SA , Orenstein WA , eds. Vaccines. 3rd ed. Philadelphia, PA: WB Saunders Company; 1999.

9. Blatter MM , Resinger K , Bottenfield GW , et al. Evaluation of the reactogenicity and immunogenicity of a new combined Dtpa-HBV-IPV vaccine coadministered with Hib vaccine at 2, 4 & 6 months of age [abstract 638]. Presented at the 37th Annual Meeting of the Infectious Diseases Society of America; November 18-21, 1999; Philadelphia, PA.

10. Gylca R , Gylca V , Benes O , et al. A new DTPa-HBV-IPV vaccine co-administered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth. Vaccine. 2001;19:825-833.

11. Usonis V , Bakasenas V. Does concomitant injection of combined diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus vaccine influence the reactogenicity and immunogenicity of commercial Haemophilus influenzae type b conjugate vaccines? Eur J Pediatr. 1999;158:398-402.

12. Pichichero ME , Blatter MM , Reisinger KS , et al. Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheriatetanus-acellular pertussis-hepatitis Binactivated poliovirus-Haemophilus influenzae type b combination vaccination. Pediatr Infect Dis J. 2002;21:854-859.

13. Greenberg DP , Wong VK , Partridge S , et al. Safety and immunogenicity of a combination DTPa-hepatitis B vaccine administered at 2, 4, and 6 months of age compared with monovalent hepatitis B vaccine administered at birth, 1, and 6 months of age. Pediatr Infect Disj In press.

14. Centers for Disease Control and Prevention . Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). MMWR. 1999;48(RR-5):1-15.

15. Greenberg DP , Pickering LK , Senders SD , et al. Interchangeability of 2 diphtheria-tetanus-acellular pertussis vaccines in infancy. Pediatrics. 2002;109:666-672.

16. Martin JA , Hamilton BE , Ventura SJ , et al. Births: final data for 2000. Natl Vital Stat Rep. 2002;50:1-104.