PER-009-09已完成未知
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
OVARTIS VACCINES AND DIAGNOSTICS,0 个研究点目标入组 534 人开始时间: 2009年4月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 534
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 2（—）
- 性别
- All
入选标准
- •Healthy infants 2 months of age (55 to 89 days). In countries where the children´s series begins at 6 weeks of age, the inclusion window for age is 37 to 71 days. Babies must have been born after a full-term pregnancy with an estimated gestational age> 37 weeks and a weight> 2.5 kg at birth;
- •your parent or legal representative must have given your informed written consent after the nature of the study has been explained to you;
- •must be available for all scheduled study visits;
- •must have a good state of health, as determined by: the medical history, the physical examination, the clinical criteria of the investigator.
排除标准
- •must not have previously received any meningococcal or D, T, P, IPV or OPV vaccine, H. influenzae type b (Hib) or Pneumococcus; previous doses of BCG (one) and / or HBV (two) are allowed
- •must not have a confirmed or suspected previous illness caused by N. memngitidis. C. diphtheriae, C. tetani, polio virus, hepatitis B, Hib, Pneumococcus or B. permssis (history of confirmed laboratory tests, or clinical condition of paroxysmal cough for a period of 2 weeks or more associated with apnea or pertussis) ;
- •must not have had contact at home and / or close exposure with any that have confirmed laboratory tests of N. meningitidis (serogroups A, C, W, Y), B. pertussis, Hib, C. diphtheriae, poliomyelitis or infection pneumococcal at any time from birth;
- •must not have a history of anaphylactic shock, asthma, hives or other allergic reaction after previous vaccinations, or known hypersensitivity to any of the components of the vaccine;
- •must not have experienced significant acute or chronic infection within the previous 7 days, nor should they have experienced fever (axillary temperature> 38.0´C [100.4 ° F]) within the previous 3 days;
- •should not have or suspect any serious (eg leukemia, lymphomas) or chronic disease (eg, with signs of heart disease, kidney failure, severe malnutrition or insulin-dependent diabetes), progressive neurological disease or genetic abnormality / known cytogenic disorders (eg, Down syndrome);
- •should not have or suspect an autoimmune disease or persistent dysfunction / alteration of immune function caused (for example) by: having received some immunosuppressive therapy at any time since birth, having received immunostimulants at any time since birth, having received some systemic corticosteroid from birth;
- •should not suspect or know of an HIV infection or HIV-related disease;
- •must not have received blood, blood products and / or plasma derivatives, or any parenteral immunoglobulin preparations;
- •must not have a known hemorrhagic diathesis, or any condition that may be associated with a prolonged bleeding time;
- •They should not have a history of seizures or seizures;
- •Your parents / legal representatives should not have plans to leave the study center area before the end of the study period;
- •they must not have any condition that, in the opinion of the researcher, may interfere with the evaluation of the objectives of the study;
- •They should not have received any investigational agent or vaccine from birth, nor should they have planned to receive an investigational agent or vaccine before the end of the study.
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