"a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 239
- 试验地点
- 7
- 主要终点
- Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)
研究概览
简要总结
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.
详细描述
Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has received full (3-dose) infant series of Prevnar 13
排除标准
- •Prior vaccination with any 7vPnC.
- •Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
- •Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
结局指标
主要结局
Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)
时间窗: Baseline up to Month 36
MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
次要结局
未报告次要终点