NCT01270503已完成4 期
Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 538
- 试验地点
- 79
- 主要终点
- Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
研究概览
简要总结
This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
详细描述
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 to 11 years of age on the day of inclusion (Group 1)
- •Aged 12 to 17 years of age on the day of inclusion (Group 2)
- •Aged 18 to 55 years of age on the day of inclusion (Group 3)
- •Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
- •Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
- •Provision of informed consent form signed by the subject (Group 3)
- •If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
- •Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
- •For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).
排除标准
- •For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
- •Breast-feeding woman
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •Planned receipt of any vaccine during the present trial period
- •Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
- •History of seizures
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
- •Personal of family history of Guillain-Barré Syndrome.
研究组 & 干预措施
Menactra® Group 1
Experimental
Participants aged 2 to 11 on enrollment
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Menactra® Group 2
Experimental
Participants aged 12 to 17 on enrollment
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
Menactra® Group 3
Experimental
Participants aged 18 to 55 on enrollment
干预措施: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Biological)
结局指标
主要结局
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
时间窗: Day 0 up to Day 30 post-vaccination
次要结局
- Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®(Day 0 up to Day 30 post-vaccination)
研究者
研究点 (79)
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