A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
研究概览
简要总结
This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults 18 to 49 years of age.
- •Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.
- •Negative serum pregnancy test for all female subjects who are of childbearing potential.
排除标准
- •Baseline laboratory test results outside of the normal reference range considered clinically significant.
- •History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine.
- •History of culture-proven invasive disease caused by S pneumoniae.
- •Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- •Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation.
- •Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.
研究组 & 干预措施
Multivalent
Pneumococcal conjugate vaccine
干预措施: Multivalent (Biological)
Tdap
Tetanus, diphtheria, and pertussis vaccine
干预措施: Tdap (Biological)
结局指标
主要结局
Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
时间窗: 6 months after vaccination
Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site).
时间窗: Day 15
Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, chills, rash, decreased appetite, nausea/vomiting, new muscle pain, aggravated muscle pain, new joint pain, and aggravated joint pain).
时间窗: Day 15
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.
时间窗: 1 month after vaccination
Percentage of subjects with clinical laboratory abnormalities after vaccination.
时间窗: Day 6
次要结局
- Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination.(1 month after vaccination)
- Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination.(1 month after vaccination)