NCT02447978已完成不适用
Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
研究概览
简要总结
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 47 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
- •The 5th dose was given between the ages of 47 and 84 months.
- •All 5 DTaP doses received were manufactured by GSK, depending on study objective (otherwise this criterion will not apply).
- •Born in 1999 and later.
- •Inclusion criteria for cases:
- •All individuals meeting above inclusion criteria who tested PCR-positive for pertussis and negative for parapertussis during the study period.
- •Inclusion criteria for PCR-negative controls:
- •All individuals meeting above inclusion criteria who tested PCR-negative for both pertussis and parapertussis during the study period.
- •Inclusion criteria for KPNC-matched controls:
- •All individuals from the general KPNC population meeting above inclusion criteria who match a PCR-positive case on sex, age, race or ethnic group, and medical center.
- •KPNC members on the day their matched case under-went the PCR test (anchor date).
排除标准
- •Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
- •Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
- •Individuals who received reduced antigen content pertussis vaccine (Tdap) or any pertussis-containing vaccine after their 5th DTaP dose but before their PCR test date (or anchor date).
- •Exclusion criteria for controls:
- •Individuals will be excluded from serving as a control once they test positive for pertussis.
结局指标
主要结局
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
时间窗: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
时间窗: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
次要结局
- Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)(Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine)
- Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)(Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine)
研究者
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