A Descriptive, Phase IV, Open-label, Single-arm Multi-center Study to Assess the Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Healthy Toddlers 12 to 23 Months of Age Who Had Been Primed With at Least 1 Dose of Another Quadrivalent Meningococcal Conjugate Vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in Infancy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W
研究概览
简要总结
This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD).
Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments.
Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.
详细描述
Study duration was approximately 30 days (+14 days) per participant
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12 to 23 months on the day of inclusion
- •Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator
- •Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose
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 study (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
- •Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
- •Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- •Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine
- •Receipt of immunoglobulins, 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
- •NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
MenACYW conjugate vaccine
participants received a single booster dose of the MenACYW conjugate vaccine with an interval of at least 2 months after the last vaccination with Nimenrix® or Menveo® received during infancy before 12 months of age
干预措施: MenACYW conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA).
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:16 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA)
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA).
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:32 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid
时间窗: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay.
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
时间窗: Up to 30 minutes post-vaccination on Day 1
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
时间窗: Up to 7 days post-vaccination on Day 1
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability.
Number of Participants With Unsolicited Adverse Events
时间窗: Up to 30 days post-vaccination on Day 1
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
时间窗: From vaccination (Day 1) up to 30 days post vaccination, 31 days
An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate.
次要结局
未报告次要终点