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临床试验/EUCTR2013-002918-12-HU
EUCTR2013-002918-12-HU进行中(未招募)1 期

Randomized, prospective, double blind clinical study to evaluate the effectiveness, dosage and safety of lactobacillus vaccine for management of bacterial vaginosis in a non-selected patient population - LATVAC

Amvac Kft0 个研究点开始时间: 2013年8月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 1.18 years or above
  • 2.Mentally competent
  • 3.Written informed consent
  • 4.Being able to comply with the protocol
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 400
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Hypersensitivity to formaldehyde, or any other of the components of Gynevac
  • 3.Acute infectious disease
  • 4.Immunosuppression
  • 5.Acute polyarthritis
  • 6.Serious cardiac, liver or kidney diseases
  • 7.Abnormalities of the blood circulation or of the hemopoetic system
  • 8.Ongoing antibiotic treatment
  • 9.Use of any investigational drug within 30 days of V0
  • 10. No former antibiotic treatment for any reasons in 14 days before study entry

研究者

发起方
Amvac Kft

相似试验

ATVAC (Lactobacilli Therapeutic Vaccine study) | 临床试验