A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Severe Solicited Adverse Event
研究概览
简要总结
Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.
Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5).
The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues.
This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).
Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose.
The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation.
The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.
入排标准
- 年龄范围
- 12 Months 至 16 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age);
- •For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;
- •Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits);
- •Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)
排除标准
- •History of any meningococcal vaccine administration.
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment.
- •History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
- •Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination.
- •Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
- •Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
- •Severe acute malnutrition.
- •A family history of congenital or hereditary immunodeficiency.
- •History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection.
- •Major congenital defects.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed).
- •Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
- •Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination.
- •Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
- •Malaria infection as confirmed by a Rapid Diagnostic Test.
- •Individuals who are close family members of individuals conducting this study.
- •Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment.
- •Have received systemic antibiotic treatment within 3 days prior to enrolment.
- •Non-residence in the study area or intent to move out within six months.
- •Any condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
研究组 & 干预措施
Adjuvanted study formulation NmCV-5
Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
干预措施: Adjuvanted study formulation NmCV-5 (Biological)
Non-adjuvanted study formulation NmCV-5
Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
干预措施: Non-adjuvanted study formulation NmCV-5 (Biological)
Menactra
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
干预措施: Menactra (Biological)
结局指标
主要结局
Severe Solicited Adverse Event
时间窗: 7 days post each vaccination
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
次要结局
- Geometric Mean of rSBA Titres(112 Days)
- Adverse Events(112 Days)
- Serious Adverse Events(168 Days)
- Other Adverse Events(168 Days)
- Seroprotective rSBA Titres(112 days)
- Long Term Protective rSBA Titres(112 days)
- Rise in rSBA Titres(112 days)
- Solicited Reactions(7 days post each vaccination)