NCT01000311已完成3 期
A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Novartis Vaccines92 个研究点 分布在 3 个国家目标入组 529 人开始时间: 2009年11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
- 529
- 试验地点
- 92
- 主要终点
- Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
研究概览
简要总结
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
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
- 55 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg.
- •Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.
- •Parent/legal representative was available for all visits scheduled in the study.
- •Subjects were in good health as determined by:
- •medical history
- •physical assessment
- •clinical judgment of the investigator
排除标准
- •Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
- •Subjects who had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, poliovirus, Hepatitis B, Hib, pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping).
- •Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
- •Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
- •Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
- •Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
- •Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
- •Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
- •Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
- •Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
- •Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •Subjects who received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
- •Subjects who were relatives of site research staff working on this study.
结局指标
主要结局
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
时间窗: Baseline and one month after fourth-dose of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
次要结局
- Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM(Baseline and one month after third infant dose of MenACWY-CRM)
- hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM(Baseline and one month after fourth-dose of MenACWY-CRM)
- hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM(Baseline and one month after third infant dose of MenACWY-CRM)
- Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone(One month after third dose of routine infant series vaccination)
- Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone(One month after third dose of routine infant series vaccination)
- Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone(One month after PCV toddler vaccination)
- Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone(One month after PCV toddler vaccination)
- Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination(Baseline and Six months after third infant dose of MenACWY-CRM)
- Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination(Baseline and Six months after third infant dose of MenACWY-CRM)
- Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM(One month after MenACWY-CRM toddler vaccination)
- Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations(From day 1 to 18 months)
研究者
研究点 (92)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In InfantsMeningitis, MeningococcalNCT00474526Novartis Vaccines4,545
已完成
3 期
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the USHealthy Volunteers (Meningococcal Infection)NCT03537508Sanofi Pasteur, a Sanofi Company2,627
已完成
3 期
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy InfantsInfections, MeningococcalNCT02106390GlaxoSmithKline750
Unknown
3 期
A Study of a Candidate COVID-19 Vaccine (COV003)CoronavirusNCT04536051University of Oxford10,300
已完成
3 期
Phase 3 Pivotal Trial of NanoFlu™ in Older AdultsInfluenza, HumanNCT04120194Novavax2,654