NCT04936685进行中（未招募）3 期
A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine With 5- and/or 10-year Booster Doses in Children and Adolescents Who Had Been Primed With MenACYW Conjugate Vaccine as Toddlers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 209
- 试验地点
- 53
- 主要终点
- Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
研究概览
简要总结
The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose.
详细描述
The duration of each participant's participation will be approximately 5.5 years
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
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
- •Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
- •Covered by health insurance, if required by local regulations
排除标准
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- •At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
- •Personal history of Guillain-Barré syndrome (GBS)
- •Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- •Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1
Experimental
Participants will receive a first booster dose of MenACYW conjugate vaccine at Day 1 and a second booster dose at year 5 of study MEQ00073
干预措施: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (Biological)
Group 2
Experimental
Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073
干预措施: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (Biological)
结局指标
主要结局
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
时间窗: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.
次要结局
- Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)(Within 30 minutes after vaccination)
- Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination(At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51))
- Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
- Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions(7 days after vaccination)
- Group 1: Number of Participants With Unsolicited AEs(Within 30 days after vaccination)
- Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration(From Baseline (Day 1) until end of the study (approximately 5.5 years))
- Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)(From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks)
- Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration(Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose)
研究者
研究点 (53)
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