ACTRN12618000822280已完成未知
Verification of Pneumococcal IgG Antibody Responses to 23vPPV in Healthy Controls Using an Automated ELISA
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 2 Years 至 25 Years（—）
- 性别
- All
入选标准
- •Each adult must meet all of the following criteria to be enrolled in this study
- •-Is between the ages of 18 and 25 years at the time of enrolment
- •-Is capable of understanding the informed consent document and providing consent
- •-Is available to attend for the study follow up
- •Each child must meet all of the following criteria to be enrolled in this study:
- •-Is between the ages of 2 and 5 years at the time of enrolment
- •-Has received Prevenar13 as per the Australian National Immunisation Program Schedule at 2-, 4-, and 6-months of age
- •-Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
- •-Is available to attend for the study follow up
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •-Prior immunisation with 23vPPV
- •-Has a known hypersensitivity to any of the components of the 23vPPV vaccine
- •-Has a current fever or infection
- •-Is taking immunosuppressant medication, e.g. oral corticosteroids
- •-Has a prior diagnosis of invasive pneumococcal infection
- •-Has a pre-existing medical condition associated with increased risk of invasive pneumococcal disease (adapted from Immunisation Handbook)
- •*functional or anatomical asplenia
- •*immunocompromising conditions, including
- •**congenital or acquired immune deficiency
- •**haematological or other malignancies
- •**solid organ transplant
- •**haematopoietic stem cell transplant
- •**human immunodeficiency virus (HIV) infection
- •**chronic renal failure, or relapsing/persistent nephrotic syndrome
- •*proven or presumptive cerebrospinal fluid leak
- •*cochlear implants
- •*intracranial shunts
- •*chronic cardiac disease
- •*chronic lung disease
- •*chronic liver disease
- •*diabetes mellitus
- •*Down syndrome
- •*alcoholism
- •*preterm birth <28 weeks gestation
- •-Is currently pregnant, or considering pregnancy during the study period
- •-Is known to require a pneumococcal immunisation prior to the completion of the study follow up
- •-Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
- •In addition, for adult participants, the following exclusion criteria apply:
- •-Prior immunisation with a pneumococcal conjugate vaccine
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