A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 20
- 主要终点
- Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
研究概览
简要总结
One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 23 Months 至 27 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female children, 23 to 27 months of age (naïve children)
- •Available for all the visits scheduled in the study;
- •For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
- •Available for all the visits scheduled in the study;
- •In good health as determined by medical history, physical examination, clinical judgment of the investigator.
- •Healthy children who participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrolment in V72P13E2;
- •Who received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 according to the protocols;
- •Who provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (groups B246_12M12/B246_12M13) or after their second dose of rMenB+OMV NZ (groups B13_15_27/B12_14_26) in V72P13E1 according to the protocol;
- •For whom parent(s)/legal guardian(s) had given written informed consent after the nature of the study has been explained;
- •In good health as determined by medical history, physical examination, clinical judgment of the investigator.
排除标准
- •Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
- •History of any meningococcal B vaccine administration;
- •Previous ascertained or suspected disease caused by N. meningitidis;
- •For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
- •History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •Antibiotics treatment within 6 days prior to enrolment;
- •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
- •Any serious chronic or progressive disease
- •Known or suspected impairment/ alteration of the immune system,
- •Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
- •Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day;
- •Family members and household members of research staff;
- •Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
- •Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrolment (use of low or moderate doses of inhaled steroids is not an exclusion);
- •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment;
- •Participation in another clinical trial within 90 days prior to enrolment or planned for during study;
- •Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment);
- •Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
结局指标
主要结局
Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
时间窗: 12 months post booster (fourth) vaccination.
To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).
Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.
时间窗: 12 months post booster (fourth) vaccination.
To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).
Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.
时间窗: 12 months post booster (fourth) vaccination.
To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953. Analysis was done on MITT population (Primary).
次要结局
- GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.(12 months post two catch-up dose vaccination and 6 months post booster dose.)
- Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.(6month post booster dose and 12 months post two catch-up dose vaccination.)
- GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.(1 month and 6 months post two catch-up doses.)
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.(Up to 7 days after any vaccination.)
- Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.(1 month post booster dose versus prebooster.)
- Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.(1 month post two catch-up doses versus prevaccination)
- GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.(1 month and 6 months post two catch-up doses.)
- Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.(Up to 7 days after any vaccination)
- GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.(12 months post two catch-up dose vaccination and 6 months post booster dose.)
- Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.(1 month and 6 months post two catch-up doses.)
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.(Up to 7 days after any vaccination.)
- Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.(Up to 7 days after any vaccination.)