2023-510145-25-00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
Sanofi Pasteur, Sanofi Pasteur18 个研究点 分布在 4 个国家目标入组 209 人开始时间: 2024年5月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 209
- 试验地点
- 18
- 主要终点
- Vaccine seroresponse against meningococcal serogroups A, C, W, and Y
研究概览
简要总结
• The purpose of the MEQ00073 study is to evaluate the immunogenicity and safety of a booster dose and describe the immune persistence of a priming dose of MenACYW conjugate vaccine in children and adolescents in Finland, Germany, Spain, and Hungary, who had been vaccinated with MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers as part of the MET51 study, and to describe the immunogenicity and safety of a second booster dose and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as children. • To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of MenACYW conjugate vaccine in children who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier as toddlers (Group 1)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 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
- •Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, 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)
- •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
- •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
- •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
结局指标
主要结局
Vaccine seroresponse against meningococcal serogroups A, C, W, and Y
Vaccine seroresponse against meningococcal serogroups A, C, W, and Y
次要结局
- Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2)
- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2)
- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1)
- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1)
- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2)
- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1)
- Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1)
- Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1)
- Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2)
- Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1)
- Antibody titers against meningococcal serogroup C Visit 2 and Visit 3 (Group 2)
- Number of participants with immediate unsolicited systemic adverse events (AEs)
- Number of participants with solicited injection site reactions and systemic reactions
- Number of participants with unsolicited AEs
- Number of participants with serious adverse events (SAEs) and Adverse Event of Special Interest (AESI)
研究者
研究点 (18)
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