A Phase 1, Randomized, Double-Blind, Comparator-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V132 in Healthy Older Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 9
- 主要终点
- Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
研究概览
简要总结
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health
- •Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 (inclusive)
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
- •Has received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study
研究组 & 干预措施
Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
干预措施: V132 Formulation 1 (Biological)
Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
干预措施: V132 Formulation 3 (Biological)
Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
干预措施: PREVNAR 20™ (Biological)
Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
干预措施: CAPVAXIVE™ (Biological)
Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
干预措施: V132 Formulation 1 (Biological)
Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
干预措施: V132 Formulation 2 (Biological)
Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
干预措施: V132 Formulation 3 (Biological)
Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
干预措施: PREVNAR 20™ (Biological)
Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
干预措施: CAPVAXIVE™ (Biological)
Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
干预措施: V132 Formulation 2 (Biological)
结局指标
主要结局
Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
时间窗: Up to approximately 30 minutes post vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with immediate reactions occurring within 30 minutes after any vaccination will be reported.
Percentage of Participants with a Solicited Injection-site Adverse Event
时间窗: Up to approximately 7 days post vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. The percentage of participants with a solicited injection-site adverse event will be reported.
Percentage of Participants Who Experienced an Adverse Event of Clinical Interest
时间窗: Up to approximately 12 months post vaccination
Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). The percentage of participants who experienced an adverse event of clinical interest will be reported.
Percentage of Participants with a Solicited Systemic Adverse Event
时间窗: Up to approximately 7 days post vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with a solicited systemic adverse event will be reported.
Percentage of Participants With at Least 1 Unsolicited Adverse Event
时间窗: Up to approximately 28 days post vaccination
An unsolicited AE is an AE that was not solicited using a vaccination report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with at least 1 unsolicited adverse event will be reported.
Percentage of Participants with a Serious Adverse Event
时间窗: Up to approximately 12 months post vaccination
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs will be reported.
Percentage of Participants With at Least 1 Medically Attended Adverse Event
时间窗: Up to approximately 12 months post vaccination
A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The percentage of participants with at least 1 MAAE will be reported.
次要结局
- Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)(Up to approximately 28 days post vaccination)
- Geometric Mean Fold Rise from Baseline of Serotype-specific OPA(Baseline (pre-vaccination) and 28 days post vaccination)