RPCEC00000188尚未招募2 期
Phase II clinical trial, controlled, randomized, double-blind to assess the immunogenicity of the live vaccine candidate against cholera of the attenuated 638 Vibrio cholerae O1 El Tor Ogawa (CV638), in Cuban volunteers from 5 to 65 years old.
Finlay Institute, Center for Research Developing and Productions of Vaccines0 个研究点目标入组 410 人开始时间: 2014年11月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
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
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 5 years 至 45 years（—）
- 性别
- All
入选标准
- •1.Volunteer of whatever sex, apparently healthy from 5 to 45 years old, whose health condition has been established by medical criteria by mean of anamnesis and physical examination before the beginning of the study.
- •2.Expressed willfulness by mean of written informed consent signed by the adult subjet (from 18 or more years old).
- •3.Expressed willfulness by mean of written informed consent signed by the adolescent or child subject´s father, mother or legal tutor from 5 to 17 years old.
- •4.Expressed willfulness by mean of the signed assent by the adolescent subject from 10 to 17 years old.
排除标准
- •1.Volunteers with serum vibriocidal antibodies titer major or equal to 320, five days before the administration of CV638 or Shanchol® vaccine.
- •2. Seropositive volunteer to IgG cholera antitoxin by mean the ELISA test, five days before the administration of CV638 or Shanchol® vaccine.
- •3. Acute disease detected in the previous week to the administration of CV638 or Shanchol® vaccine.
- •4. Axillary temperature like or higher than 37.5 ° C immediately before the administration of CV638 or Shanchol® vaccine.
- •5. Personal history of chronic disease.
- •6. Personal history of immunosuppressive treatment (systemic steroids, cytostatics, etc.) or immunostimulants medicines (interferons, transfer factor, gamma globulins, levamisole, etc.) in the 30 days prior, excluding steroids given topicaly or by inhalation.
- •7. History of therapy with immunoglobulin or blood derived products, during the 6 months prior to administration of CV638 or Shanchol® vaccine.
- •8. History of antibiotic therapy, current or during the 10 days prior to the administration of CV638 or Shanchol® vaccine.
- •9. History of cholera infection in the last 3 years.
- •10. Previous history of immunization with cholera vaccine.
- •11. To be a food handler.
- •12. Childcare workers of children under 5 years old.
- •13. History of allergy reactions to any component of the investigational product or antacid and intolerance to milk or lactose.
- •14. History of allergic reactions to formaldehyde or thiomersal.
- •15. Positive pregnancy test in women, adolescents and post menstruant girls.
- •16. Pregnancy.
- •17. Breastfeeding.
研究者
相似试验
进行中（未招募）
1 期
Pilot study about the use of intravenous Vitamin C for the prevention of Reperfusion Syndrome in Orthotopic Liver Transplantation from a cadaver donor.EUCTR2020-000123-39-ESFundación Investigación Biomédica Hospital Ramón y Cajal70
进行中（未招募）
1 期
Clinical trial with L-asparaginase encapsulated in erythrcoytes in patients affected by metastatic pancreatic cancer after first line treatmentMedDRA version: 16.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864Pancreatic cancerEUCTR2013-004262-34-FRERYTECH Pharma90
招募中
不适用
Phase II, randomized, double-blind clinical trial for efficacy of Granulocyte-colony stimulating factor(G-CSF) and autologous cord blood infusion in children with cerebral palsyKCT0002512Hanyang University Seoul Hospital98
进行中（未招募）
1 期
Clinical trial to evaluate the efficacy and safety of Solanum malacoxylon 9CH in patients with calcific tendinitis of shoulderCalcific tendinitis of shoulderEUCTR2015-003238-29-ESFundación Sociedad Española de Médicos de Atención Primaria (SEMERGEN)104
尚未招募
2 期
Evaluation of G-CSF treatment of patients with chagasic cardiomyopathy.RBR-6tnw2bFundação Oswaldo Cruz