A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age.

ovartis Vaccines & Diagnostics0 个研究点目标入组 2,820 人开始时间: 2014年12月5日最近更新: 2015年1月6日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 2,820

研究概览入排标准研究者记录与标识符相似试验

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. who are 2-10 years of age inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent and who have given written assent, if applicable;
•2. who are available for all visits and telephone calls scheduled for the study;
•3. who are in good health as determined by:
•medical history
•physical assessment
•clinical judgment of the investigator
•4. who are up-to-date with age-appropriate routine childhood vaccinations
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2820
•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

•1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study or who are unwilling or unable to give written informed assent to participate in the study;
•2. whose parent or legal guardian is perceived to be unreliable or unavailable for the duration of the study period;
•3. who had a previous or suspected disease caused by N. meningitidis;
•4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
•5. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational) (Exception: Receipt of OMP-containing Hib vaccines is permitted);
•6. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
•7. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within 30 days after vaccination (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
•8. who have received a live viral vaccine within 30 days prior to enrollment;
•9. who have experienced within the 7 days prior to enrollment significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature 38°C) within 3 days prior to enrollment;
•Reason for delaying blood draw:
•Antibiotics in the blood may interfere with the evaluation of antibodies (i.e., by Serum Bactericidal Activity), therefore a blood draw should be postponed if the subject has received oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw.
•10. who have any serious acute, chronic or progressive disease such as
•history of cancer (excluding minor non-melanoma skin cancer)
•diabetes mellitus
•arteriosclerotic disease
•autoimmune disease
•HIV infection or AIDS
•blood dyscrasias
•congestive heart failure
•renal failure
•severe malnutrition
•11. who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome; Note: one febrile seizure is not a reason for exclusion
•12. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component including latex;
•13. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): receipt of immunosuppressive therapy within 30 days prior to enrollment (any
•systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy) receipt of immunostimulants
•receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
•14. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
•15. who have Down’s syndrome or other known cytogenic disorders;
•16. whose families are planning to leave the area of the study site before the end of the study perio

研究者

发起方

ovartis Vaccines & Diagnostics

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