PACTR201408000864165尚未招募未知
Immunogenicity and safety study of 1 and 2 doses of GSK Biologicals meningococcal vaccine GSK134612 in toddlers, persistence up to 5 years after vaccination and co-administration with Pfizers pneumococcal vaccine Prevenar 13
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 Month(s) 至 14 Month(s)（—）
- 性别
- All
入选标准
- •Subjects parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.
排除标准
- •Child in care.
- •Use of any investigational/non-registered product other than the study vaccines within 30 days and administration of immunoglobulins and/or any blood products within 3 months, both before the 1st dose of study vaccine or planned use during the study period.
- •Chronic administration of immunosuppressants/other immune-modifying drugs within 6 months prior to the 1st vaccine dose.For corticosteroids,this will mean prednisone 0.5 mg/kg/day,or equivalent.Inhaled and topical steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting and ending 30 days before and after the dose of vaccines,with the exception of a licensed inactivated influenza vaccine.MMR/MMRV vaccine can be co-administered with MenACWY-TT and/or Prevenar 13.A DTPa containing vaccine can be administered after the last blood sampling.
- •Concurrently participating in another clinical study,at any time during the study period,in which the subject has been or will be exposed to an investigational/a non-investigational vaccine/product.
- •Previous vaccination against Neisseria meningitidis.
- •Previous booster vaccination against Streptococcus pneumoniae,Corynebacterium diphtheriae,Clostridium tetani and Bordetella pertussis.
- •History of meningococcal disease.
- •Any confirmed/suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection,based on medical history and physical examination
- •Note:With the exception of HIV rapid testing which will be done for subjects in South Africa.
- •Family history of congenital/hereditary immunodeficiency.
- •History of any reaction or hypersensitivity, including to diphtheria toxoid,likely to be exacerbated by any component of the vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures,including Guillain-Barré syndrome except simple,single febrile seizure.
- •Acute disease and/or fever at the time of enrolment.
研究者
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