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AAP Grand Rounds 3:58-59 (2000)
© 2000 American Academy of Pediatrics

INFECTIOUS DISEASES

Heptavalent Pneumococcal Conjugate Vaccine

Source: Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187–195.

The first 20% of the full text of this article appears below.

In this landmark study, Black and colleagues report the results of a large-scale, double-blind trial of the recently licensed heptavalent CRM197 pneumococcal conjugate vaccine (Prevnar, Wyeth Lederle) carried out in 23 northern California medical centers. They assessed safety, immunogenicity, and vaccine efficacy among 37,868 infants immunized at 2, 4, 6, and 12–15 months of age with either pneumococcal conjugate (18,927) or a control meningococcal type C conjugate vaccine (18,941). Routine childhood vaccines including DTwP or DTaP; OPV or IPV; Hib; HB; MMR; and varicella were administered at the recommended ages. The conjugate pneumococcal vaccine was well tolerated and highly immunogenic. Vaccine efficacy was assessed after 40 invasive infections caused by pneumococcal serotypes included in the heptavalent vaccine occurred in fully vaccinated enrollees. Efficacy was 97% (95% CI, 83–100%) among fully vaccinated recipients of pneumococcal vaccine (39/40 invasive isolates were recovered from controls) and 94% (95% CI, 80–99%) among fully or incompletely vaccinated recipients (49/52 invasive isolates from controls). Analysis of all invasive isolate serotypes (including non-vaccine types) yielded 89% vaccine efficacy, with 55/61 invasive isolates recovered from controls (P<.001). Importantly, . . . [Full Text of this Article]

Stanford T. Shulman, MD, FAAP
Pediatric Infectious Diseases, Children’s Memorial Hospital, Northwestern University Medical Center, Chicago, IL

 



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