一项了解成人新型肺炎球菌疫苗的安全性和免疫反应的研究
多价肺炎球菌结合疫苗在 18 岁及以上成人中的安全性和免疫原性的 1/2 期随机双盲试验
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.
This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.
Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.
Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.
Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.
Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.
Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
研究概览
地位
条件
干预/治疗
- 生物：Multivalent Pneumococcal Vaccine - Formulation 3
- 生物：Multivalent Pneumococcal Vaccine - Formulation 1
- 生物：20-valent pneumococcal conjugate vaccine (20vPnC)
- 生物：Multivalent Pneumococcal Vaccine - Formulation 2
- 生物：Licensed pneumococcal comparator vaccine
- 生物：Multivalent Pneumococcal Vaccine - Formulation 4
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Florida
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Doral、Florida、美国、33172
- Alliance for Multispecialty Research, LLC
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Hialeah、Florida、美国、33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge、Georgia、美国、30281
- Clinical Research Atlanta
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Illinois
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Peoria、Illinois、美国、61614
- Optimal Research
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Louisiana
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New Orleans、Louisiana、美国、70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield、Michigan、美国、48034
- Headlands Research - Detroit
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New York
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Rochester、New York、美国、14609
- Rochester Clinical Research, LLC
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Tarrytown、New York、美国、10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington、North Carolina、美国、28401
- Accellacare - Wilmington
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Tennessee
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Knoxville、Tennessee、美国、37909
- AMR Clinical
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Knoxville、Tennessee、美国、37920
- AMR Clinical
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Texas
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Brownsville、Texas、美国、78526
- Headlands Horizons LLC
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Houston、Texas、美国、77065
- DM Clinical Research- Cyfair
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San Antonio、Texas、美国、78229
- IMA Clinical Research San Antonio
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San Antonio、Texas、美国、78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland、Texas、美国、77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball、Texas、美国、77375
- DM Clinical Research
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Tomball、Texas、美国、77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City、Utah、美国、84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City、Utah、美国、84109
- J. Lewis Research, Inc.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
- Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
- Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
- Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
- Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
- Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
- Known or suspected immunodeficiency or other conditions associated with immunosuppression
- Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
Multivalent pneumococcal conjugate vaccine |
|
实验性的：Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
有源比较器：Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20vPnC. |
20-valent pneumococcal conjugate vaccine (20vPnC)
其他名称：
|
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实验性的：Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
有源比较器：Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
A licensed pneumococcal comparator vaccine |
|
实验性的：Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
Multivalent pneumococcal conjugate vaccine |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of participants reporting prespecified local reactions within 7 days after vaccination
大体时间：7 days
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Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination |
7 days
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Percentage of participants reporting prespecified systemic events within 7 days after vaccination
大体时间：7 days
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Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination |
7 days
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Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
大体时间：1 month
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Adverse events occurring within 1 month after vaccination |
1 month
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Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
大体时间：6 months
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SAEs occurring within 6 months after vaccination |
6 months
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Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
大体时间：12 months
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Related SAEs occurring through 12 months after vaccination |
12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
大体时间：1 month after vaccination
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Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
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合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- C4931001
- NCT06182124 (注册表标识符：ClinicalTrials.gov)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.