EUCTR2014-004617-82-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 Children, Adolescents and Adults in Russia
ovartis Vaccines and Diagnostics SR0 个研究点目标入组 198 人开始时间: 2014年11月7日最近更新:
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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
- 198
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 were those
- •1. who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study was described and:
- •? the parent/legal representative had provided written informed consent (=2 to <18years of age);
- •? had provided written assent (=11 to <18 years of age);
- •? had provided written informed consent (=18 years of age onwards).
- •2. who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (eg, completion of the diary card, return for follow-up visit).
- •3. who were in good health as determined by:
- •? medical history;
- •? physical exam;
- •? clinical judgment of the investigator.
- •4. who had a negative urine pregnancy test for female subjects from 11 years of age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 132
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Individuals not eligible to be enrolled in the study were those:
- •1. who were unwilling or unable to give written informed assent or consent to participate
- •in the study;
- •2. who were perceived to be unreliable or unavailable for the duration of the study
- •3. who had a previous confirmed 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 had previously been immunized with a meningococcal vaccine or vaccine
- •containing meningococcal antigen(s) (licensed or investigational);
- •6. who were pregnant or breast feeding (female subjects);
- •7. who had received any investigational or nonregistered product (drug or vaccine)
- •within 28 days prior to enrolment or who expected to receive an investigational drug
- •or vaccine prior to the completion of the study;
- •8. who had received any vaccines within 14 days (for inactivated vaccines) or 28 days
- •(for live vaccines) prior to enrolment in this study or who were 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);
- •9. who had experienced within the 7 days prior to enrolment, a significant acute
- •infection (for example requiring systemic antibiotic treatment or antiviral therapy) or
- •had experienced fever (defined as body temperature ?38°C) within 3 days prior to
- •10. who had any serious acute, chronic or progressive disease (eg, 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) and who had epilepsy or any progressive neurological disease or history
- •of Guillain-Barre syndrome;
- •11. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any
- •vaccine components including diphtheria toxin (CRM-197) and latex in the syringe;
- •12. who had 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 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 30 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 were known to have a bleeding diathesis, or any condition that may be associated
- •with a prolonged bleeding time.
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