NCT01229397已完成3 期
A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule
Crucell Holland BV4 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 4
- 主要终点
- Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
研究概览
简要总结
The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children
- •Aged ≥6 to <36 months on Day 1
- •Born at a gestational age ≥37 weeks
- •Written informed consent
- •No previous influenza vaccination
排除标准
- •Acute respiratory infection or other acute disease
- •Acute febrile illness (≥38.0 °C)
- •Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
- •Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
- •Known hypersensitivity to any vaccine component
- •Known history of egg protein allergy or severe atopy
- •Known blood coagulation disorder
- •Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed)
- •Known immunodeficiency (including leukemia, cancer, HIV seropositivity)
- •Investigational medicinal product received in the past 3 months (90 days)
- •Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- •Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period
- •Participation in another clinical trial
- •Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee
- •Suspected non-compliance
结局指标
主要结局
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
时间窗: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Seroprotection rate
次要结局
- Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability(Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy ToddlersMeningococcal MeningitisMeaslesMumpsRubellaVaricellaNCT00384397Sanofi Pasteur, a Sanofi Company1,128
已完成
2 期
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate VaccineInfections, MeningococcalNCT00126984GlaxoSmithKline508
进行中（未招募）
2 期
Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and AboveHerpes ZosterNCT05856084MAXVAX Biotechnology Limited Liability Company924
已完成
3 期
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy ChildrenHaemophilus Influenzae Type b (Hib) InfectionNCT01125527Novartis Vaccines700
已完成
3 期
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and OlderPneumococcal VaccinesPneumococcal Conjugate VaccineNCT01646398Pfizer764