NCT01310400已完成3 期
Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal
Crucell Holland BV1 个研究点 分布在 1 个国家目标入组 1,356 人开始时间: 2009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
- 1,356
- 试验地点
- 1
- 主要终点
- Immunogenicity, Assessed by the Haemagglutination (HI) Test
研究概览
简要总结
A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
- •Recording of medical history and physical examination reveal no abnormality
- •The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization
排除标准
- •Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
- •Previous vaccination against influenza
- •At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
- •Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
- •Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
- •Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study
- •Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
- •At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
- •Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
- •Family history of Guillain-Barré Syndrome
- •Severe congenital deficiency or disease
- •Antecedent of neurological disease or epileptic attack
- •Severe cardiopulmonary disease with possibility to influence the study result
- •Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
- •Suspected non-compliance
结局指标
主要结局
Immunogenicity, Assessed by the Haemagglutination (HI) Test
时间窗: 3 weeks after the 2nd vaccination
Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of \<1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.
次要结局
- Fold Increase in Geometric Mean Titer (GMT)(3 weeks after the 2nd vaccination)
- Safety: Incidence of Solicited and Unsolicited Adverse Events(Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end)
- Seroprotection(3 weeks after the 2nd vaccination)
研究者
研究点 (1)
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