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
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
- 4
- 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.
研究组 & 干预措施
Group 1
This group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' alone on the different visits.
干预措施: Combined inactivated hepatitis A & recombinant hepatitis B (Biological)
Group 2
This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.
干预措施: Combined inactivated hepatitis A & recombinant hepatitis B (Biological)
Group 3
This group will receive only MenACWY-CRM.
干预措施: MenACWY-CRM (Biological)
Group 2
This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.
干预措施: Inactivated hepatitis A vaccine (Biological)
Group 2
This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.
干预措施: Recombinant hepatitis B vaccine (Biological)
Group 2
This group will receive Inactivated hepatitis A vaccine and recombinant hepatitis B Vaccine or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' concomitantly with MenACWY-CRM.
干预措施: MenACWY-CRM (Biological)
Group 1
This group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' alone on the different visits.
干预措施: Inactivated hepatitis A vaccine (Biological)
Group 1
This group will receive Inactivated hepatitis A and recombinant hepatitis B or 'Combined inactivated hepatitis A & recombinant hepatitis B vaccine' alone on the different visits.
干预措施: Recombinant hepatitis B vaccine (Biological)
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
- 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.)
- Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29(28 days postvaccination (day 29).)