NCT00606359已完成2 期
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Anti-HA individual titers
研究概览
简要总结
Primary Objective:
To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).
Secondary Objective:
To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine
详细描述
The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •Subject with renal transplant for at least 6 months.
- •Subject with stable renal function, i.e. with a variation of creatinin value < 20% and with a creatinin clearance estimated according to Cockroft and Gault calculation > 20 mL/min during the 3 months preceding inclusion.
- •Aged 18 to 59 years on the day of the screening visit.
- •Informed Consent Form signed.
- •Subject entitled to national social security.
- •Subject under immunosuppressive therapy.
- •For a woman, inability to bear a child or negative urine pregnancy test.
- •Subject non-responder to previous IM vaccination with the 2006-2007 Northern Hemisphere Vaxigrip® formulation.
排除标准
- •Subject with sign of transplanted kidney reject within 3 months preceding vaccination according to medical practice.
- •Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- •Febrile illness (oral temperature ≥ 37.5°C, or rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
- •Breast-feeding.
- •Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Congenital immunodeficiency, anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- •Chronic illness, except renal failure or renal disorders, at a stage that could interfere with trial conduct or completion.
- •Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- •Blood or blood-derived products received in the past 3 months .
- •Any vaccination in the 4 weeks preceding the trial vaccination.
- •Vaccination planned in the 4 weeks following the trial vaccination.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- •Previous vaccination against influenza in the preceding 6 months.
- •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
结局指标
主要结局
Anti-HA individual titers
时间窗: 21 Days Post-vaccination 2
Individual titers ratio
时间窗: 21 Days Post-vaccination 2
Seroconversion or significant increase
时间窗: 21 Days Post-vaccination 2
次要结局
- Safety: Adverse events in the first 21 days after each vaccination; Pre-listed reactions in the 7 days following each vaccination; Serious adverse events during the entire trial.(21 days following each vaccination)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in InfantsInfluenzaNCT01494740Shanghai Institute Of Biological Products312
进行中（未招募）
不适用
Immunogenicity of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with Intramuscular Vaccination with Vaxigrip® in Adults.EUCTR2005-002401-23-DESanofi Pasteur SA978
进行中（未招募）
不适用
Immunogenicity of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with Intramuscular Vaccination with Vaxigrip® in Adults.Annual vaccination of healthy adult (18-60 years) for 3 consecutive years.Classification code 10036897EUCTR2005-002401-23-BESanofi Pasteur SA978
进行中（未招募）
4 期
Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal VaccineHand, Foot and Mouth DiseaseNCT06209398Jiangsu Province Centers for Disease Control and Prevention510
进行中（未招募）
不适用
Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip in the Elderly - NDVaccination of elderly subjects aged 60 years and over with inactivated, split-virion inf luenza vaccine administered by the intradermal route using Vaxigrip as IM reference vaccineMedDRA version: 6.1Level: SOCClassification code 10021881EUCTR2006-002366-18-ITSANOFI PASTEUR3,655