NCT01453348已完成3 期
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
Novartis Vaccines8 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2011年10月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 8
- 主要终点
- Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
研究概览
简要总结
This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals eligible for enrollment in this study were female and male subjects who had shown to be healthy and who were:
- •Between 18 and 64 years of age inclusive and who had given their written informed consent;
- •Available for all visits and telephone calls scheduled for the study;
- •In good health as determined by medical history, physical examination and clinical judgment of the investigator;
- •For female subjects, had a negative urine pregnancy test.
排除标准
- •Individuals not eligible to be enrolled in the study were those:
- •Who were breastfeeding.
- •Who had a previous personal history of Neisseria meningitidis, hepatitis A or hepatitis B infection.
- •Who received previous immunization with any meningococcal vaccine.
- •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.
- •Who received investigational agents or vaccines within 30 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to completion of the study.
- •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 was anticipated during the study period (Exception: Influenza vaccine might have been administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization).
- •Who experienced, within the 7 days prior to enrollment, 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 enrollment.
- •Who had any serious acute, chronic or progressive disease such as:
- •History of cancer
- •Complicated diabetes mellitus
- •Advanced arteriosclerotic disease
- •Autoimmune disease
- •HIV infection or AIDS
- •Blood dyscrasias
- •Congestive heart failure
- •Renal failure
- •Severe malnutrition (Note: Subjects with mild asthma were eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment).
- •Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome.
- •Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy and antibiotic allergy.
- •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 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);
- •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.
- •Who were known to have a bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
- •Who had any condition that, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
- •Who were part of the study personnel or close family members of those conducting this study.
结局指标
主要结局
Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination
时间窗: Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.
Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.
次要结局
- Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29(28 days postvaccination (day 29).)
- hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29(28 days post vaccination (day 29).)
- Percentages of Subjects With Unsolicited Adverse Events (AEs)(Day 1 to day 57.)
- Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination(28 days post primary or booster vaccination.)
研究者
研究点 (8)
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