NCT00856297已完成3 期
An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine
Novartis Vaccines63 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 试验地点
- 63
- 主要终点
- Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
研究概览
简要总结
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in V59P13:
- •healthy subjects who have completed the V59P13 study.
- •Naïve subjects:
- •healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).
排除标准
- •Subjects who had completed the V59P13 study:
- •who received any meningococcal vaccine after the V59P13 trial;
- •who have had previous confirmed or suspected disease caused by N. meningitidis;
- •who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- •subjects with any serious, acute or chronic progressive disease.
- •Naïve subjects:
- •who previously received any meningococcal vaccine;
- •who have had previous confirmed or suspected disease caused by N. meningitidis;
- •who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- •subjects with any serious, acute or chronic progressive disease.
结局指标
主要结局
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
时间窗: 21 months, 3 years and 5 years postvaccination
Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.
次要结局
- hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination(day 1)
- Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine(1 month post booster vaccination)
- Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator(Day 1 to 5 years)
- Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine(28 days postvaccination)
- Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine(21 months, 3 years and 5 years postvaccination)
- Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8(day 1)
- Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine(2 years postvaccination)
- Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine(2 years postvaccination)
- hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine(21 months, 3 years and 5 years postvaccination)
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events(Day 1 to Day 7)
研究者
研究点 (63)
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