NCT00329849已完成3 期
A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age
Novartis Vaccines3 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2006年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
研究概览
简要总结
Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 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 (Participant)
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 inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
- •Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
- •Good health as determined by the clinical judgment of the investigator.
排除标准
- •Individuals not eligible to be enrolled into the study were those:
- •whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
- •whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period;
- •who had a previous or suspected disease caused by N meningitidis;
- •who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
- •who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
- •who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
- •who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
- •who had received a live viral vaccine within 60 days prior to enrollment;
- •who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment;
- •who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
- •who had epilepsy or any progressive neurological disease;
- •who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
- •who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- •receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
- •receipt of immunostimulants;
- •receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
- •common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
- •who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time;
- •who had Down syndrome or other known cytogenic disorders;
- •whose families were planning to leave the area of the study site before the end of the study period;
- •who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
研究组 & 干预措施
MenACWY-CRM
Experimental
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
干预措施: Meningococcal ACWY-CRM conjugate vaccine (Biological)
MenACWY-PS
Active Comparator
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS)
干预措施: Meningococcal ACWY-PS polysaccharide vaccine (Biological)
结局指标
主要结局
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
时间窗: 1 month after vaccination (day 29)
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
时间窗: Day 1 to 7 postvaccination
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
次要结局
- Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS(Day 1 and 29)
- The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS(Day 1 and 29)
- Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS(Day 181)
- The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS(Day 181)
- Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS(Day 1 to 7 postvaccination)
研究者
研究点 (3)
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