EUCTR2014-004477-16-Outside-EU/EEA进行中（未招募）不适用
A phase 3, multi-center, open-label study to evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.
ovartis Healthcare Pvt. Ltd., Vaccines Division0 个研究点目标入组 180 人开始时间: 2014年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •Individuals eligible for enrolment in this study are those:
- •who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to
- •whom the nature of the study has been explained and:
- •- the parent/legal representative has provided written informed consent (=2 - <18
- •years of age).
- •- have provided written assent (=7-<18 years)
- •- have provided written informed consent (=18 to 75 years of age).
- •2. who the investigator believes that they or their parents/legal representatives can and
- •will comply with the requirements of the protocol (e.g., completion of the Diary Card,
- •return for follow-up visit).
- •3. who are in good health as determined by
- •- medical history
- •- physical exam
- •- clinical judgment of the investigator
- •4. who have a negative urine pregnancy test for female subjects of childbearing potential
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 69
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Individuals not eligible to be enrolled in the study are those:
- •1. who are unwilling or unable to give written informed assent or consent to participate
- •in the study.
- •2. who are 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 enrolment.
- •5. who have previously been immunized with a meningococcal vaccine.
- •6. who have received any investigational or non-registered product (drug or vaccine)
- •within 28 days prior to enrolment or who expect to receive an investigational drug or
- •vaccine prior to the completion of the study.
- •7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days
- •(for live vaccines) prior to enrolment in this study or who are planning to receive any
- •vaccine within 30 days from the study vaccines.
- •(Exception: Influenza vaccine may be administered up to 15 days prior to study
- •vaccination and at least 15 days after study vaccination)
- •8. who have experienced within the 7 days prior to enrolment significant acute 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
- •9. who have any serious acute, chronic or progressive disease (e.g., any history of
- •neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
- •AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe
- •malnutrition).
- •10. who have epilepsy or any progressive neurological disease.
- •11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any
- •vaccine components.
- •12. 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 28 days prior to enrolment (any
- •systemic corticosteroid administered for more than 5 days, or in a daily dose > 1
- •mg/kg/day prednisone or equivalent during any of 28 days prior to enrolment, or
- •cancer chemotherapy)
- •- receipt of immunostimulants
- •- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
- •derivatives within 90 days prior to enrolment and for the full length of the study
- •13. who are known to have a bleeding diathesis, or any condition that may be associated
- •with a prolonged bleeding time.
- •14. who have any condition that, in the opinion of the investigator, might interfere with
- •the evaluation of the study objectives.
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