A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 20
- 主要终点
- Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
研究概览
简要总结
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations
排除标准
- •Unwilling or unable to give written informed assent or consent to participate in the study.
- •Perceived to be unreliable or unavailable for the duration of the study period.
- •Previous confirmed or suspected disease caused by N. meningitidis.
- •Previously immunized with a meningococcal vaccine (licensed or investigational).
- •Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
- •Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
- •(certain exceptions influenza vaccines apply)
- •Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
- •Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
- •History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
- •Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- •receipt of immunosuppressive therapy,
- •receipt of immunostimulants,
- •receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
- •Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
研究组 & 干预措施
2 through 5 years (1 Vac) MenACWY-CRM 1
Subjects 2 through 5 years received one vaccination of MenACWY-CRM
干预措施: MenACWY-CRM (Biological)
6 through 10 years (1 Vac) MenACWY-CRM 3
Subjects 6 through 10 years received one vaccination of MenACWY-CRM
干预措施: MenACWY-CRM (Biological)
6 through 10 years (2 Vac) MenACWY-CRM 4
Subjects 6 through 10 years received two vaccinations of MenACWY-CRM
干预措施: MenACWY-CRM (Biological)
2 through 5 years (2 Vac) MenACWY-CRM 2
Subjects 2 through 5 years received two vaccinations of MenACWY-CRM
干预措施: MenACWY-CRM (Biological)
结局指标
主要结局
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
时间窗: One Month After Last Vaccination ( day 86)
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
时间窗: One Month After Last Vaccination (day 86)
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
次要结局
- Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM(One Month After Last Vaccination (day 86))
- Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM(One Month After Last Vaccination (day 86))
- Number of Subjects Who Reported Selected AEs After Any Vaccination(Day 1 to Day 422)
- Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM(One year after one vaccination or two vaccinations (day 422).)
- Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination(From Days 1-7 after each vaccination)
- Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination(From Days 1-7 after each vaccination)
- Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM(One year after one vaccination or two vaccinations (day 422).)