A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75 Years of Age in India.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
研究概览
简要总结
This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals eligible for enrollment in this study are those:
- •who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and:
- •the parent/legal representative has provided written informed consent (greater than or equal to 2 - less than 18 years of age).
- •have provided written assent (greater than or equal to 7-less than or equal to 18 years)
- •have provided written informed consent (greater than or equal to 18 to 75 years of age).
- •who the investigator believes that they or their parents/legal representatives can and will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
- •who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
- •who have a negative urine pregnancy test for female subjects of childbearing potential.
排除标准
- •Individuals not eligible to be enrolled in the study are those:
- •who are unwilling or unable to give written informed assent or consent to participate in the study.
- •who are perceived to be unreliable or unavailable for the duration of the study period.
- •who had a previous or suspected disease caused by N. meningitidis.
- •who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
- •who have previously been immunized with a meningococcal vaccine.
- •who have received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
- •who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are 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)
- •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 greater than or equal to 38°C) within 3 days prior to enrollment.
- •who have any serious acute, chronic or progressive disease (e.g., 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).
- •who have epilepsy or any progressive neurological disease.
- •who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
- •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 28 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose greater than 1 mg/kg/day prednisone or equivalent during any of 28 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 any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究组 & 干预措施
MenACWY - 2 - 10 Years old
Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1.
干预措施: Meningococcal ACWY conjugate vaccine (Biological)
MenACWY - 11 - 18 Years old
Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.
干预措施: Meningococcal ACWY conjugate vaccine (Biological)
MenACWY - 19 - 75 Years old
Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.
干预措施: Meningococcal ACWY conjugate vaccine (Biological)
结局指标
主要结局
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
时间窗: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
时间窗: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
时间窗: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
时间窗: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
次要结局
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.(Day 29 (ie, 1 month post vaccination))
- hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1(Day 1)
- hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29(Day 29 (ie, 1 month post vaccination))
- Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination(From day 1 to Day 7 post vaccination)
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29(Day 29 (ie, 1 month post vaccination))
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.(Day 29 (ie, 1 month post vaccination))
- hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29(Day 29 ( ie, 1 month post vaccination))
- hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1(Day 1)
- hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1(Day 1)
- hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29(Day 29 (ie, 1 month post vaccination))
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.(Day 1)
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.(Day 1)
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.(Day 29)
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1(Day 1)
- hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29(Day 29 (ie, 1 month post vaccination))
- hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1(Day 1)
- Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination(From day 1 to Day 7 post vaccination)
- Number of Subjects With Unsolicited Adverse Events(Day 1 through day 29)
- Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.(Day 1)