A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines 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
- Novartis
- 入组人数
- 552
- 试验地点
- 9
- 主要终点
- Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
研究概览
简要总结
This study compares the safety and immunogenicity profile of several travel vaccines 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male subjects who must be healthy and must be:
- •Between 18 and 60 years of age inclusive and who have 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, having a negative urine pregnancy test.
排除标准
- •Individuals not eligible to be enrolled in the study are those:
- •who are breastfeeding;
- •who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection);
- •who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;
- •who have 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;
- •who have 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);
- •who have received an anti-malaria drug, up to 2 months prior to the study;
- •who have 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;
- •who have 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 are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment);
- •who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- •who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy;
- •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 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 are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •who have myasthenia gravis; thyroid or thymic disorders,
- •who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
- •who are part of the study personnel or close family members of those conducting this study.
- •for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.
研究组 & 干预措施
TF + YF + MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
干预措施: MenACWY-CRM Vaccine (Biological)
JE + Rab + MenACWY-CRM197
Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
干预措施: MenACWY-CRM Vaccine (Biological)
MenACWY-CRM197 (Combined)
Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
干预措施: MenACWY-CRM Vaccine (Biological)
结局指标
主要结局
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
时间窗: Baseline and 1 month post last vaccination (day 57).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
时间窗: Baseline and 1 month post last vaccination (day 57).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-typhoid Vi Antibody Concentrations
时间窗: Baseline and 1 month postvaccination (day 29).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-Yellow Fever Antibody Titer
时间窗: Baseline and 1 month postvaccination (day 29).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
次要结局
- Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone(Baseline and 1 month post last vaccination (day 57).)
- Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone(Baseline and 1 month post last vaccination (day 57).)
- Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone(Baseline and 1 month postvaccination (day 29).)
- Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197(Baseline and 1 month post last vaccination (day 57).)
- Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197(Baseline and 1 month post last vaccination (day 57).)
- Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone(day 1 to day 57 post last vaccination)
- Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone(Baseline and 1 month postvaccination (day 29).)
- Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone(1 month postvaccination (day 29))
- Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone(Baseline and 1 month post last vaccination (day 29 or day 57).)
- Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone(1 month post last vaccination (day 29 or day 57))