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Amsub #10 Black S536-S549 . REPORTS . Efficacy, Safety, and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Children Steven Black, MD; Henry Shinefield, MD; Bruce Fireman, MA; Edwin Lewis, MPH; Paula Ray, MPH; John R. Hansen, BA; Laura Elvin; Kathy M. Ensor, RN; Jill Hackell, MD; George Siber, MD; Frank Malinoski, MD, PhD; Dace Madore, PhD; Ih Chang, PhD; Robert Kohberger, PhD; Wendy Watson, MD; Robert Austrian, MD; Kathy Edwards, MD; and The Northern California Kaiser Permanente Vaccine Study Center Group* Abstract pneumococcal conjugate vaccine, or Objective: To determine the effica- meningococcus type C CRM197 conju- cy, safety, and immunogenicity of the gate. The primary study outcome was heptavalent CRM197 pneumococcal invasive disease caused by vaccine conjugate vaccine (PCV) against inva- serotype. Other outcomes included sive disease caused by vaccine overall impact on invasive disease serotypes and to determine the effec- regardless of serotype, effectiveness tiveness of this vaccine against clinical against clinical otitis media visits and episodes of otitis media. episodes, and impact against frequent Methods: The Wyeth Lederle and severe otitis media and ventilato- heptavalent CRM197 PCV was given ry tube placement. In addition the to infants at 2, 4, 6 and 12 to 15 serotype-specific efficacy against oti- months of age in a double-blind trial; tis media was estimated in an analysis 37,868 children were randomly of spontaneously draining ears. assigned 1:1 to receive either the Results: In the interim analysis in August 1998, 17 of the 17 cases of invasive disease caused by vaccine From the Kaiser Permanente Vaccine Study serotype in fully vaccinated children Center, Oakland, CA (SB, HS, BF, EL, PR, JRH, LE, KME); Wyeth Lederle Vaccines and Pediatrics, and 5 of 5 of partially vaccinated cases Pearl River, NY (JH, GS, FM, DM, IC, RK, WW); occurred in the control group for a University of Pennsylvania, School of Medicine, vaccine efficacy of 100%. Blinded Philadelphia, PA (RA); and Vanderbilt University case ascertainment was continued Medical Center, Nashville, TN (KE). until April 1989. As of that time 40 *Members of the Northern California Kaiser Permanente Vaccine Study Center Group: Drs. fully vaccinated cases of invasive dis- Janet Aguilar, Marissa Bartlett, Randy Bergen, ease caused by vaccine serotype had Mel Burman, Steve Dorfman, Wayne Easter, been identified, all but 1 in controls for Annette Finkel, Hervey Froehlich, James an efficacy of 97.4% (95% confidence Glauber, Arnd Herz, David Honeychurch, Robert Klainrock, Irene Landaw, Allan Lavetter, interval, 82.7% to 99.9%), and 52 Chinh Le, Steve McMurtry, Pius Morozumi, Pat cases, all but 3 in controls in the Mullin, Michael Rehbein, Richard Rossin, intent-to-treat analysis for an efficacy Garwin Soe, Irene Takahashi, Gail Udkow, of 98.9% (95% confidence interval, Robert Whitson. 79.6% to 98.5%). There was no evi- Address correspondence to: Steven Black, MD, Kaiser Permanente Vaccine Study Center, 1 dence of any increase of disease Kaiser Plaza, Oakland, CA 94612. Fax: 510-267- caused by nonvaccine serotypes. 7524; E-mail: [email protected]. Efficacy for otitis media against visits, This article originally appeared in Pediatr episodes, frequent otitis, and ventilato- Infec Dis J 2000;19:187-195. Reprinted with per- mission. Copyright © 2000 by Lippincott ry tube placement was 8.9%, 7.0%, Williams & Wilkins, Inc. 9.3% and 20.1% with P < 0.04 for all. S536 THE AMERICAN JOURNAL OF MANAGED CARE JULY 2000 . HEPTAVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN CHILDREN . In the analysis of spontaneously drain- overwhelming sepsis. Unlike Hib, ing ears, serotype-specific effective- where only one serotype accounted ness was 66.7%. for virtually all H. influenzae disease, Conclusion: This heptavalent there are more than 90 described pneumococcal conjugate appears to serotypes of the pneumococcus, be highly effective in preventing inva- many of which cause disease in adults sive disease in young children and to and children. However, within the have a significant impact on otitis United States 7 serotypes are respon- media. sible for 83% of invasive disease in (Am J Manag Care 2000;6(suppl):S536-S549) children younger than 4 years of age. We report the results of the Kaiser Permanente trial evaluating the effica- cy, safety, and immunogenicity of the heptavalent pneumococcal conjugate lthough the pneumococcus vaccine (Wyeth; PNCRM7) conducted was first isolated more than in Northern California between A 100 years ago and the first October 1995 and August 1998 and pneumococcal vaccine trials began in the posttrial blinded efficacy follow- 1911, there is still no routinely rec- up through April 20, 1999. ommended pneumococcal vaccine for use in childhood. The currently avail- . able 23-valent pneumococcal polysac- METHODS charide vaccine is not effective in This study was a randomized, dou- children younger than 2 years of age ble-blind trial conducted at 23 med- in whom 80% of invasive pneumococ- ical centers within Northern cal disease in childhood occurs. This California Kaiser Permanente vaccine has also not been effective in (NCKP). The study was approved by the control of otitis media in children. the Institutional Review Board of the During recent years there has been Kaiser Foundation Research Institute. considerable effort devoted toward Written informed consent was developing a pneumococcal vaccine obtained from parents or guardians. A that is effective in infants and chil- Study Advisory Committee (Drs. dren. After the licensure of conjugate Donna Ambrosino, William Haemophilus influenzae type b (Hib) Blackwelder, and Jerome Klein) mon- vaccines in late 1990, there has been itored the conduct of the study and a more than 98% elimination of Hib functioned as a Safety Monitoring disease in this country.1 This leaves Committee. the pneumococcus as the most com- Healthy infants were randomized mon cause of bacterial meningitis in 1:1 to receive either the heptavalent young children. In addition there has pneumococcal conjugate or the been a rapid emergence of drug-resis- meningococcus type C conjugate vac- tant pneumococci that have caused cine at 2, 4, 6, and 12 to 15 months of invasive infection worldwide and in age. Children with sickle-cell disease, the United States.2 The increasing known immunodeficiency, any seri- prominence of pneumococcal infec- ous chronic or progressive disease, a tions and of antimicrobial resistance history of seizures, or a history of has emphasized the need for the either pneumococcal or meningococ- development of an effective vaccina- cal disease were excluded. tion program to reduce the risk of The pneumococcal conjugate vac- pneumococcal disease in childhood. cine contained 2µg each of saccha- The pneumococcus is responsible rides of serotypes 4, 9V, 14, 18C, 19F, for a wide spectrum of infection rang- and 23F and 4µg of 6B coupled to the ing from asymptomatic carriage to protein carrier CRM197 (a nontoxic VOL. 6, NO. 10, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S537 . REPORTS . mutant of diphtheria toxin). The con- pneumococcal disease. To be included trol meningococcal conjugate vaccine in the main efficacy analysis, cases contained 10µg of group C oligosac- must have been caused by a pneumo- charide conjugated to the same carri- coccal serotype included in the vac- er protein. The 2 vaccines were cine, must have occurred longer than identical in appearance. Multiple lots 14 days after the third dose of study of both the pneumococcal and vaccine, and must have occurred in meningococcal conjugate vaccines subjects vaccinated according to pro- were used in this study. The following tocol. In addition potential cases were routine childhood vaccines were tested for immunocompetence evalu- administered at the recommended ated by obtaining quantitative ages: diphtheria-tetanus toxoid-whole immunoglobulins, a complete blood cell pertussis vaccine (DTwP) or diph- count with differential, and CD4/CD8 theria-tetanus toxoid-acellular pertus- cell counts. sis vaccine (DTaP); oral poliovirus This trial incorporated a sequen- vaccine or inactivated poliovirus vac- tial design with an interim evaluation cine; Hib; hepatitis B; measles- by the Study Advisory Committee at mumps-rubella vaccine; varicella. 17 cases in fully vaccinated per pro- Initially all subjects received TETRA- tocol cases of invasive disease caused MUNE (a vaccine combining by vaccine serotype in fully vaccinat- Haemophilus b conjugate and DTwP) ed immunocompetent children. For into the opposite leg and oral each child follow-up ended for the poliovirus vaccine concurrently. When main efficacy analysis at the earliest recommendations changed the proto- of the following dates: the onset of col was amended to allow administra- invasive pneumococcal disease of any tion of DTaP and inactivated poliovirus serotype; the child died; or at the end vaccine. Vaccines not given concomi- of the trial. A child younger than 16 tantly were given at least 2 weeks apart months of age was considered fully from study vaccine. vaccinated if the child had received 3 or more doses of vaccine, and a child Efficacy 16 months of age or older was consid- The primary endpoint for the eval- ered fully vaccinated after receipt of a uation of efficacy of the pneumococ- fourth dose of vaccine. Protective effi- cal conjugate vaccine was the cacy was estimated by calculating the protective efficacy of the heptavalent ratio of the number of cases of inva- pneumococcal conjugate vaccine sive disease in the pneumococcal
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