Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children
TL;DR: The Wyeth Lederle as discussed by the authors determined the efficacy, safety and immunogenicity of the CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media.
Abstract: Objective.To determine the efficacy, safety and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media.Methods.The Wyeth Lederle
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TL;DR: The findings show that the interventions needed to achieve the millennium development goal of reducing child mortality by two-thirds by 2015 are available, but that they are not being delivered to the mothers and children who need them.
2,430 citations
TL;DR: The use of the pneumococcal conjugate vaccine is preventing disease in young children, for whom the vaccine is indicated, and may be reducing the rate of disease in adults.
Abstract: Background In early 2000, a protein–polysaccharide conjugate vaccine targeting seven pneumococcal serotypes was licensed in the United States for use in young children. Methods We examined population-based data from the Active Bacterial Core Surveillance of the Centers for Disease Control and Prevention to evaluate changes in the burden of invasive disease, defined by isolation of Streptococcus pneumoniae from a normally sterile site. Serotyping and susceptibility testing of isolates were performed. We assessed trends using data from seven geographic areas with continuous participation from 1998 through 2001 (population, 16 million). Results The rate of invasive disease dropped from an average of 24.3 cases per 100,000 persons in 1998 and 1999 to 17.3 per 100,000 in 2001. The largest decline was in children under two years of age. In this group, the rate of disease was 69 percent lower in 2001 than the base-line rate (59.0 cases per 100,000 vs. 188.0 per 100,000, P<0.001); the rate of disease caused by va...
2,135 citations
TL;DR: The mechanism and epidemiology of colonisation, the complexity of relations within and between species, and the consequences of the different preventive strategies for pneumococcal colonisation are discussed.
Abstract: Streptococcus pneumoniae is an important pathogen causing invasive diseases such as sepsis, meningitis, and pneumonia. The burden of disease is highest in the youngest and oldest sections of the population in both more and less developed countries. The treatment of pneumococcal infections is complicated by the worldwide emergence in pneumococci of resistance to penicillin and other antibiotics. Pneumococcal disease is preceded by asymptomatic colonisation, which is especially high in children. The current seven-valent conjugate vaccine is highly effective against invasive disease caused by the vaccine-type strains. However, vaccine coverage is limited, and replacement by non-vaccine serotypes resulting in disease is a serious threat for the near future. Therefore, the search for new vaccine candidates that elicit protection against a broader range of pneumococcal strains is important. Several surface-associated protein vaccines are currently under investigation. Another important issue is whether the aim should be to prevent pneumococcal disease by eradication of nasopharyngeal colonisation, or to prevent bacterial invasion leaving colonisation relatively unaffected and hence preventing the occurrence of replacement colonisation and disease. To illustrate the importance of pneumococcal colonisation in relation to pneumococcal disease and prevention of disease, we discuss the mechanism and epidemiology of colonisation, the complexity of relations within and between species, and the consequences of the different preventive strategies for pneumococcal colonisation.
1,770 citations
TL;DR: The heptavalent pneumococcal polysaccharide-CRM197 conjugate vaccine is safe and efficacious in the prevention of acute otitis media caused by the serotypes included in the vaccine.
Abstract: Background Ear infections are a common cause of illness during the first two years of life. New conjugate vaccines may be able to prevent a substantial portion of cases of acute otitis media caused by Streptococcus pneumoniae. Methods We enrolled 1662 infants in a randomized, double-blind efficacy trial of a heptavalent pneumococcal polysaccharide conjugate vaccine in which the carrier protein is the nontoxic diphtheria-toxin analogue CRM197. The children received either the study vaccine or a hepatitis B vaccine as a control at 2, 4, 6, and 12 months of age. The clinical diagnosis of acute otitis media was based on predefined criteria, and the bacteriologic diagnosis was based on a culture of middle-ear fluid obtained by myringotomy. Results Of the children who were enrolled, 95.1 percent completed the trial. With the pneumococcal vaccine, there were more local reactions than with the hepatitis B vaccine but fewer than with the combined whole-cell diphtheria–tetanus–pertussis and Haemophilus influenzae t...
1,466 citations
TL;DR: This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) andAmerican Academy of Family Physicians and provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM.
Abstract: This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of children from 6 months through 12 years of age with uncomplicated AOM. In 2009, the AAP convened a committee composed of primary care physicians and experts in the fields of pediatrics, family practice, otolaryngology, epidemiology, infectious disease, emergency medicine, and guideline methodology. The subcommittee partnered with the Agency for Healthcare Research and Quality and the Southern California Evidence-Based Practice Center to develop a comprehensive review of the new literature related to AOM since the initial evidence report of 2000. The resulting evidence report and other sources of data were used to formulate the practice guideline recommendations. The focus of this practice guideline is the appropriate diagnosis and initial treatment of a child presenting with AOM. The guideline provides a specific, stringent definition of AOM. It addresses pain management, initial observation versus antibiotic treatment, appropriate choices of antibiotic agents, and preventive measures. It also addresses recurrent AOM, which was not included in the 2004 guideline. Decisions were made on the basis of a systematic grading of the quality of evidence and benefit-harm relationships. The practice guideline underwent comprehensive peer review before formal approval by the AAP. This clinical practice guideline is not intended as a sole source of guidance in the management of children with AOM. Rather, it is intended to assist primary care clinicians by providing a framework for clinical decision-making. It is not intended to replace clinical judgment or establish a protocol for all children with this condition. These recommendations may not provide the only appropriate approach to the management of this problem.
1,246 citations
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Book•
13 Mar 1991
TL;DR: The Martingale Central Limit Theorem as mentioned in this paper is a generalization of the central limit theorem of the Counting Process and the Local Square Integrable Martingales (LSIM) framework.
Abstract: Preface. 0. The Applied Setting. 1. The Counting Process and Martingale Framework. 2. Local Square Integrable Martingales. 3. Finite Sample Moments and Large Sample Consistency of Tests and Estimators. 4. Censored Data Regression Models and Their Application. 5. Martingale Central Limit Theorem. 6. Large Sample results of the Kaplan-Meier Estimator. 7. Weighted Logrank Statistics. 8. Distribution Theory for Proportional Hazards Regression. Appendix A: Some Results from stieltjes Integration and Probability Theory. Appendix B: An Introduction to Weak convergence. Appendix C: The Martingale Central Limit Theorem: Some Preliminaries. Appendix D: Data. Appendix E: Exercises. Bibliography. Notation. Author Index. Subject Index.
1,997 citations
01 Nov 1998
TL;DR: Females had more procedures than males, and the rate of procedures increased with age in ambulatory and inpatient settings, in the United States during 1996.
Abstract: Objectives This report presents estimates of surgical and nonsurgical procedures performed in the United States during 1996. Data are presented by characteristics of patients, region of the country, and procedure categories for ambulatory and inpatient procedures separately and combined. Methods Estimates in this report are based on data collected from the National Hospital Discharge Survey (NHDS) and the National Survey of Ambulatory Surgery-(NSAS). NHDS provides data on hospital inpatient care, and NSAS provides data on ambulatory surgery in hospitals and in freestanding ambulatory surgery centers. For NHDS, data were collected for approximately 282,000 discharges from 480 non-Federal short-stay hospitals (95 percent response rate). For NSAS, data were collected for approximately 125,000 ambulatory surgery discharges from 488 hospitals and freestanding ambulatory surgery centers (81 percent response rate). Results An estimated 71.9 million procedures were performed on 39.9 million discharges from hospitals and freestanding ambulatory surgery centers during 1996: 40.4 million procedures were for inpatients, and 31.5 million were for ambulatory patients. Females had more procedures than males, and the rate of procedures increased with age in ambulatory and inpatient settings. The leading procedures for ambulatory surgery patients and inpatients combined were arteriography and angiocardiography, endoscopy of small intestine, endoscopy of large intestine, and extraction of lens.
648 citations
TL;DR: Recently, resistance to and clinical failure of the extended-spectrum cephalosporins ceftriaxone and cefotaxime in the treatment of pneumococcal meningitis have been noted in Spain and the United States.
Abstract: The resistance of Streptococcus pneumoniae to penicillin and other antimicrobial agents is increasing in many parts of the world. The frequency of erythromycin resistance in parts of Europe1 and, to a lesser extent, in the United States2 limits the usefulness of macrolide antibiotics for the treatment of pneumonia, and resistance to trimethoprim-sulfamethoxazole, chloramphenicol, and tetracycline is an important problem in some other countries3,4. Recently, resistance to and clinical failure of the extended-spectrum cephalosporins ceftriaxone and cefotaxime in the treatment of pneumococcal meningitis have been noted in Spain5,6 and the United States7,8. In addition, there have . . .
547 citations
TL;DR: One year after immunization, carriage of antibiotic-resistant vaccine-type pneumococci in children receiving conjugate vaccine was lower than that inChildren receiving the nonconjugate vaccine (4% vs. 14%, P = .042).
Abstract: Children 12-18 months old were randomized to receive one dose of a conjugate heptavalent pneumococcal vaccine, two doses of the same vaccine, or one dose of a 23-valent native polysaccharide vaccine. Before immunization, pneumococci included in the conjugate vaccine were isolated from 24% of the children, and an antibiotic-resistant pneumococcus was isolated from 22% of the children. The vaccines had no effect on carriage of non-vaccine-type pneumococci. In contrast, there was a significant reduction in carriage of vaccine-type pneumococci 3 months after one dose and 1 month after a second dose of conjugate vaccine (from 25% to 9% and 7%, respectively; P < .001). No effect was seen after vaccination with the nonconjugate vaccine. One year after immunization, carriage of antibiotic-resistant vaccine-type pneumococci in children receiving conjugate vaccine was lower than that in children receiving the nonconjugate vaccine (4% vs. 14%, P = .042). Conjugate pneumococcal vaccines may reduce spread of pneumococci in the community.
480 citations
Book•
15 Jan 1995
TL;DR: The new edition of this classic text provides a critical and contemporary review of the latest medical findings on otitis media and effusion to include the latest studies of the anatomy and physiology of the Eustachian tube.
Abstract: Definitinos, Terminology, And Classification. Anatomy. Physiology, Pathophysiology, And Pathogenesis. Epidemiology. Microbiology. Immunology. Diagnosis. Management. Complications and Sequelae: Intratemporal. Complications and Sequelae: Intracranial. Index.
387 citations