NCT06165276已完成1 期
Phase I Study of the Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine in Adults, Toddlers, and Infants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 285
- 主要终点
- Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
研究概览
简要总结
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. The secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of TetraMen-T.
Primary objectives:
- To describe the safety profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
- To describe the immunogenicity profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®).
Secondary objectives:
- To describe the safety profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
- To describe the immunogenicity profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
详细描述
Up to 24 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Days 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is healthy, as determined by medical history and physical assessment.
- •At the time of vaccination on Day 0, subject was the following age: Adults: aged ≥18 to < 40 years Toddlers: aged ≥12 to < 19 months Infants: aged 2 months + 28 days (60 to 88 days)
- •Institutional Review Board (IRB)-approved informed consent form signed by the subject or the subject's parent/legal guardian.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
时间窗: Up to 28 days after injection
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
时间窗: Up to 7 days after injection
Incidence of treatment-emergent antibodies responses
时间窗: From baseline up to 24 months
Presence of serious adverse events (SAEs) throughout the trial.
时间窗: From baseline up to 24 months
次要结局
- After booster dose of TetraMen-T: Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection(Up to 7 days after injection)
- After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection(Up to 28 days after injection)
- After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.(From baseline up to 24 months)
- After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses(From baseline up to 24 months)
研究者
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