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Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children

Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children,10.1097/00006454-200003000-00003,Pediatric Infectious Di

Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children   (Citations: 561)
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STEVEN BLACK, HENRY SHINEFIELD, BRUCE FIREMAN, EDWIN LEWIS, PAULA RAY, JOHN R. HANSEN, LAURA ELVIN, KATHY M. ENSOR, JILL HACKELL, GEORGE SIBER, FRANK MALINOSKI, DACE MADOREhttp://academic.research.microsoft.com/io.ashx?type=5&id=5449856&selfId1=0&selfId2=0&maxNumber=12&query=
Objective: To determine the effica- cy, safety, and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine (PCV) against inva- sive disease caused by vaccine serotypes and to determine the effec- tiveness of this vaccine against clinical episodes of otitis media. Methods: The Wyeth Lederle heptavalent CRM197 PCV was given to infants at 2, 4, 6 and 12 to 15 months of age in a double-blind trial; 37,868 children were randomly assigned 1:1 to receive either the pneumococcal conjugate vaccine, or meningococcus type C CRM197 conju- gate. The primary study outcome was invasive disease caused by vaccine serotype. Other outcomes included overall impact on invasive disease regardless of serotype, effectiveness against clinical otitis media visits and episodes, and impact against frequent and severe otitis media and ventilato- ry tube placement. In addition the serotype-specific efficacy against oti- tis media was estimated in an analysis of spontaneously draining ears. Results: In the interim analysis in August 1998, 17 of the 17 cases of invasive disease caused by vaccine serotype in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Blinded case ascertainment was continued until April 1989. As of that time 40 fully vaccinated cases of invasive dis- ease caused by vaccine serotype had been identified, all but 1 in controls for an efficacy of 97.4% (95% confidence interval, 82.7% to 99.9%), and 52 cases, all but 3 in controls in the intent-to-treat analysis for an efficacy of 98.9% (95% confidence interval, 79.6% to 98.5%). There was no evi- dence of any increase of disease caused by nonvaccine serotypes. Efficacy for otitis media against visits, episodes, frequent otitis, and ventilato- ry tube placement was 8.9%, 7.0%, 9.3% and 20.1% with P < 0.04 for all.
Journal: Pediatric Infectious Disease Journal - PEDIAT INF DIS J , vol. 19, no. 3, pp. 187-195, 2000
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    • ...Consistent with other economic models [21,22] and the Northern California Kaiser Permanente (NCKP) trial [23], meningitis and bacteremia are defined as those caused by S. pneumoniae, whereas pneumonia and AOM cases are caused by any organism (all-cause)...
    • ...In vaccinated children <2 years, vaccination was assumed to directly reduce the probability of pneumococcal infection by the recorded efficacy of the vaccine [23] for children 2 - 4 years; efficacy was reduced to reflect waning effectiveness of the vaccine over time [22]...
    • ...To calculate herd effects on IPD in the vaccine-eligible population, we used differences in the observed changes in disease incidence from the Center for Disease Control and Prevention’s Active Bacterial Core Surveillance (ABCs) Report and direct vaccine efficacy from the NCKP trial, assuming all changes in incidence not attributable to vaccine efficacy were attributable to indirect (herd) effects [14,15,23]...
    • ...Ecologic data on pneumonia-related hospital admissions and AOM visits suggests that PCV7 vaccination may have led to larger reductions in all-cause pneumonia (39.0%) and AOM (42.7%) in children than trial efficacy data indicate [18,23,32]...
    • ...g. Adapted from the NCKP trial of PCV7 [23]; 94% (intent-to-treat) efficacy against covered serotypes, with PCV7 coverage of approximately 80% against S. pneumoniae serotypes that cause pneumococcal meningitis and bacteremia...
    • ...i. Based on intent-to-treat data from the NCKP trial for PCV7 [23]...
    • ...k. Efficacy against AOM was calculated in a manner similar to that of pneumonia; we used the midpoint between the NCKP trial estimate (6.4%) [23] and results from a study that examined changes in AOM-related outpatient visits before and after the introduction of PCV7 (42.7% reduction) [32]; our assumption of the estimated proportion of the reduction in AOM cases that is biologically plausible to be attributable to PCV7 was based on expert ...
    • ...Other sensitivity analyses included: [1] reducing assumed effectiveness of pneumococcal vaccination on AOM to 6% (reported in the NCKP trial [23]) and increasing effectiveness to the 42.7% reported by Zhou et al. [32]; [2] varying price of the vaccine by ± 10%; [3] varying incidence of invasive disease by ± 10%; and [4] varying vaccine coverage rates by ± 10 percent...

    Jaime L Rubinet al. Public health and economic impact of vaccination with 7-valent pneumoc...

    • ...The PCV7 induces a strong protective immune response in children against infection 3, but is costly and requires multiple doses, and is therefore likely not a feasible solution for less developed regions...

    Karyn L. Suttonet al. Public vaccination policy using an age-structured model of pneumococca...

    • ...More than 90 serotypes of S. pneumoniae have been isolated, and multiple serotypes have been shown to cause invasive disease in humans, as opposed to H. influenzae, in which most invasive disease was caused by Hib [11]...
    • ...Unfortunately, this vaccine is not effective in children younger than 2 years of age, a population at high risk of invasive pneumococcal disease [11]...
    • ...In the United States, seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) were responsible for more than 80% of the invasive disease caused by S. pneumoniae in young children prior to widespread pneumococcal vaccination [11]...
    • ...In February 2000, a heptavalent conjugate pneumococcal vaccine (PCNV7) was approved for use in children younger than 2 years of age [11]...

    Michael S. Benningeret al. The Impact of Vaccination on Rhinosinusitis and Otitis Media

    • ...In the US study, vaccine efficacy was reported with 97.4% against susceptible IPD in fully vaccinated individuals [8]...
    • ...IPD was reduced by 94% in the target population, due to an uptake of 83% [8]...
    • ...Cost of adverse events has also been excluded as only limited information is available [8]...

    Christa Claeset al. Cost effectiveness analysis of heptavalent pneumococcal conjugate vacc...

    • ...The advent of pneumococcal conjugate vaccines, which elicit opsonophagocytic anticapsular antibodies in infancy and protect infants and children against invasive disease, may constitute an effective strategy to reduce pneumococcal infections in these settings, as they have in developed countries (2, 3, 12)...

    Debby Bogaertet al. Impaired Innate and Adaptive Immunity to Streptococcus pneumoniae and ...

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