EUCTR2007-000683-24-CZ进行中（未招募）1 期
Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKA-H-186
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
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
- All
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female between, and including, 11 and 21 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous vaccination against varicella.
- •Known history of clinical varicella or exposure to varicella within 30 days prior to study start.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as, pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus-containing vaccines which can be administered up to eight days before each study vaccine dose.
- •Residence in the same household as a high risk person e.g. new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Rectal temperature <38°C).
- •Axillary temperature greater than or equal to 37.5°C / Rectal temperature greater than or equal to 38°C.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone greater than or equal to 0.5 mg/kg/day (or equivalent). Inhaled and topical steroids are allowed.)
研究者
相似试验
进行中（未招募）
不适用
Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKA-H-186Primary vaccination against varicella in healthy children in their second year of lifeEUCTR2007-000683-24-HUGlaxoSmithKline Biologicals240
已完成
2 期
A phase II/III clinical study to evaluate the immunogenicity and safety of three formulations of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults.CTRI/2010/091/000032Panacea Biotec Limited360
已完成
2 期
A Phase II/III clinical Study to Evaluate the Immunogenicity and Safety of Three Formulations of Monovalent H1N1 Influenza A (2009) Virus Vaccine, Manufactured by Panacea Biotec Ltd., in Healthy Pediatric Population 6 - 35 Months of Age.CTRI/2010/091/000029Panacea Biotec Limited360
已完成
2 期
A Phase II/III clinical Study to Evaluate the Immunogenicity and Safety of Three Formulations of Monovalent H1N1 Influenza A (2009) Virus Vaccine, Manufactured by Panacea Biotec Ltd., in Healthy Pediatric Population 3-9 years of Age.CTRI/2010/091/000031Panacea Biotec Limited360
已完成
不适用
Phase II, double blind, randomised, controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals Hib-menAC vaccine (Ghana)Vaccination against meningococcal diseaseInfections and InfestationsVaccinationISRCTN35754083GlaxoSmithKline (GSK) Biologicals (Ancillary study - Swiss Tropical Institute) (Belgium)280