NCT00161928已完成3 期
A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 330
- 试验地点
- 28
研究概览
简要总结
The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in 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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers infants, aged 2 to 6 months
- •Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)
- •Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation
- •Parent(s)/legal guardian and infant will be available for the duration of the study
排除标准
- •History of any vaccine-related contraindicating event (e.g. anaphylaxis)
- •Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction
- •Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period
- •Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product
- •Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
- •Subjects who have previously received a vaccination against Hep B or meningococcal C
- •Subjects who have received banked human blood or immunoglobulins within one month of study entry
研究者
研究点 (28)
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