EUCTR2011-001333-17-DE进行中（未招募）不适用
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 252 人开始时间: 2011年6月8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
- 252
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
- •Inclusion Criteria: Female and male subjects eligible to be enrolled in this study are:
- •available for all study visits,
- •able to give written informed consent,
- •18 years of age or older, and
- •generally in good health.
- •Subjects with previous vaccination against hepatitis A and/or B, determined by history (interview of the subject) and/or by review of his or her vaccination card will be eligible to participate in the study if more than 5 years have elapsed since vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 252
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •Individuals not eligible to be enrolled in the study are those:
- •1.who are breastfeeding;
- •2.who have a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection;
- •3.who received previous immunization with any meningococcal vaccine;
- •4.who received previous hepatitis A and/or B vaccination, determined by history (interview of the subject) and/or by review of his or her vaccination card, if less than 5 years have elapsed since vaccination;
- •5.who received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study;
- •6.who received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period.
- •(Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization.)
- •7.who experienced, within the 7 days prior to enrollment, 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 enrollment.
- •8.who have any serious acute, chronic or progressive disease such as
- •ohistory of cancer
- •ocomplicated diabetes mellitus
- •oadvanced arteriosclerotic disease
- •oautoimmune disease
- •oHIV infection or AIDS
- •oblood dyscrasias
- •ocongestive heart failure
- •orenal failure
- •osevere malnutrition
- •(Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment.)
- •9.who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- •10.who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy and antibiotic allergy;
- •11.who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- •oreceipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids 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);
- •oreceipt of immunostimulants;
- •oreceipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
- •12.who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •13.who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
- •14.who are part of the study personnel or close family members of those conducting this study.
研究者
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