NCT03147898已完成不适用
Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anti Pertussis antibody concentrations pre and post vaccination
研究概览
简要总结
This is an observational study designed to describe the immune profile of toddlers and preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.
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
- 15 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- •Toddler Cohort:
- •Aged 15 to 24 months on the day of (V01)
- •Has received 3 doses of a licensed pertussis-containing vaccine for a priming series during infancy in accordance with the recommendations of the NIP or his / her primary care physician
- •Has written documentation (e.g., immunization record, physician's certificate, vaccination unit registry) available to verify the receipt of 3 doses of a licensed pertussis-containing infant vaccines as per national immunization schedule
- •ICF has been signed and dated by the subject's parent(s) / legally acceptable representative(s) and, if required, an independent witness, in accordance with local regulations
- •Planned receipt of routine pertussis booster vaccine, preferably, on same date as, and no more than 2 days following, V01
- •Participant and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
- •Preschooler Cohort:
- •Aged 48 to 59 months on the date of V01
- •Has received 4 doses of pertussis-containing combination vaccines as per national immunization schedule
排除标准
- •An individual fulfilling any of the following criteria is to be excluded from study enrollment:
- •Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccine in the 4 weeks preceding the study or planned receipt of any vaccine (other than a booster pertussis vaccine) between V01 and V03a
- •Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months
- •Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the preceding 3 months
- •History of clinically- or laboratory-confirmed pertussis as per the WHO recommended case definition
- •Bleeding disorder, verbal report of thrombocytopenia, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating venipuncture, in the opinion of the investigator
- •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- •Moderate or severe acute illness/infection (in the opinion of the investigator) or febrile illness (temperature ≥ 38.0°C) at physical examination on V01 of the study. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Receipt of oral or injected antibiotics therapy within the 72 hours preceding the first blood draw. (Topical antibiotics and antibiotic drops are not included in this exclusion criterion).
- •Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study
结局指标
主要结局
Anti Pertussis antibody concentrations pre and post vaccination
时间窗: Day 30 post vaccination
The change in antibody concentrations will be measured from pre to post vaccination
Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time
时间窗: Day 30 post vaccination
The change in cell mediated immune responses will be evaluated from pre to post vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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