Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 101 人开始时间: 2003年9月1日最近更新: 2007年12月27日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 101
主要终点: To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.

详细描述

This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 2 Years 至 9 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Healthy children between
•2 to 9 years old.
•No history of antibiotic use prior 1 month of enrollment
•No history of invasive pneumococcal disease

排除标准

未提供

结局指标

主要结局

To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.

时间窗: 12 months

次要结局

To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.(12 months)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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