A placebo controlled, single-blind, single oral dose study to determine the safety and immunogenicity of M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9) in healthy paediatric subjects, aged five to 14 years inclusive, of Vietnamese origi

Emergent Product Development UK Ltd (UK)0 个研究点目标入组 150 人开始时间: 2007年2月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Healthy paediatric subjects aged five to 14 years
•2. Are able and willing to take part in the trial
•3. Parents or guardians give written permission for their child?s participation, following a detailed explanation of the study

•1. Any clinically significant medical or psychiatric condition or abnormal laboratory results on screening, which preclude participation in the study
•2. A body weight under 17 kg (five to ten year olds), or under 27 kg (11 to 14 year olds)
•3. A confirmed pregnancy, or are breast feeding
•4. A known hypersensitivity to two or more of the following antibiotics: ciprofloxacin, azithromycin or trimethoprim-sulfamethoxazole, or have used antibiotics/antibacterials within 14 days prior to administration of study medication
•5. A known hypersensitivity to any component of the vaccine or bicarbonate solution, phenylketonuria or those who have experienced anaphylactic shock after any vaccination
•6. Received Vivotif, in the last ten years or any other vaccine against S. typhi, in the last five years, or who have ever suffered from typhoid fever
•7. Direct contact with patients in special care units or immuno-compromised individuals, a positive bacterial culture of their faecal sample, obtained at the screening visit, for any Salmonella species, a known impairment of immune function or family members who are Human Immunodeficiency Virus (HIV) positive
•8. A significant acute febrile illness at time of dosing chronic diseases, a current problem of substance abuse or who are currently or recently involved in a clinical study

发起方