A multi-centre, double-blind, randomised controlled trial to evaluate the efficacy of 10 valent-pneumococcal-Protein D conjugate vaccine compared to quadrivalent (ACYW135) meningococcal conjugate vaccine in reducing respiratory exacerbations in children aged greater than or equal to 18 months with suppurative lung disease.

niversity of Queensland0 个研究点目标入组 206 人开始时间: 2012年1月9日最近更新: 2020年1月13日

适应症

试验速览

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•1. Child aged greater than or equal to 18 months and < 18 years with CSLD. The case definitions for CSLD are: a) CSLD: a clinical syndrome where there are symptoms indicating chronic endobronchial suppuration with or without HRCT evidence of radiological bronchiectasis. The main feature of the clinical syndrome is recurrent (3 or more episodes/yr) chronic (>4 weeks) wet cough responding to antibiotics b) BE: confirmed by chest HRCT scan in last 5 years c) 3 or more episodes of Protracted Bacterial Bronchitis. Protracted bacterial bronchitis is defined as the presence of isolated chronic (>4 weeks) of wet/moist cough that resolves with antibiotics in the absence of pointers suggestive of an alternative specific cause of cough. 2. Receipt of meningococcal C conjugate monovalent vaccine at least 6 months prior to enrolment. 3 Provision of written informed consent from parent/guardian (assent if child aged greater than or equal to10 years) 4. Parent/child willing and able to meet the requirements of the protocol 5. Not planning to move from the study area in the 12 months following enrolment.
•6. At least 2 respiratory exacerbations in the preceding 18 months

•Prior vaccination with PHiD-CV vaccine; contraindication to PHiD-CV and/or quadrivalent meningococcal conjugate vaccine as per the Australian Immunisation Handbook and product information sheets;10 known hypersensitivity to any component of the vaccines; confirmed or suspected immunosuppressive condition or immunodeficiency disorder; current (or within 90 days prior to receiving study vaccine) or planned (during the active study period) immunosuppressive therapy, including systemic corticosteroids (greater than14 days); administration of immunoglobulins and/or blood products with 90 days prior to receiving study vaccine, or planned administration of such products during the study period.

发起方

niversity of Queensland