A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Novartis153 个研究点分布在 6 个国家目标入组 7,744 人开始时间: 2008年12月1日最近更新: 2013年7月9日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 7,744
试验地点: 153
主要终点: Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

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

•healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
•for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
•who are available for all visits scheduled in the study;
•who are in good health as determined by medical history and physical assessment.

排除标准

•who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
•who have 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);
•who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
•who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
•who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
•who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
•who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
•receipt of any immunosuppressive therapy at any time since birth
•receipt of immunostimulants at any time since birth
•receipt of any systemic corticosteroid since birth;
•who have a suspected or known HIV infection or HIV related disease;
•who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
•who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
•who have any history of seizure;
•who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
•who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
•who have 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.
•who are relatives of site research staff working on this study.