EUCTR2014-005392-90-Outside-EU/EEA进行中（未招募）不适用
A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the Novartis MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Healthy male and female 2 month-old infants (55 – 89 days) on the day of consent.
- •2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •3. Infants whose parents or legal guardians can comply with study procedures including follow-up
- •Prior to receipt of study vaccination, subjects must be evaluated to confirm that they are
- •eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 135
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Each subject must not have/have been:
- •1. previously received any meningococcal A, C, W and Y vaccines;
- •2. previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth;
- •3. progressive, unstable or uncontrolled clinical conditions;
- •4. a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy;
- •5. 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;
- •6. any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
- •7. received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth;
- •8. ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study;
- •9. any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw;
- •10. any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study;
- •11. received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study;
- •12. received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops):
- •13. relatives of site research staff working on this study.
- •Prior to receipt of study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. At subsequent vaccinations, if subjects meet any of
- •the original exclusion criteria listed above (with exception exclusion criteria 1, previous received the study vaccine), they should not receive additional vaccinations.
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